Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT03686969
Status:
TERMINATED
Last Update Posted:
2021-04-23
First Post:
2018-08-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'Germany', 'Hungary', 'Poland', 'Romania'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003882', 'term': 'Dermatomyositis'}], 'ancestors': [{'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctgov@cllinicalresearchmgt.com', 'phone': '866-337-1868', 'title': 'Mikaela Raymond', 'organization': 'CRMG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The patient was treated according to the protocol until week 14 Treatment after week 14 was discontinued because of early study termination', 'description': 'Number of patients at risk for SAEs, All-Cause Mortality, and other adverse events in placebo group is 0 as 0 patients were enrolled into the placebo group.', 'eventGroups': [{'id': 'EG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dermatomyositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Infusion site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Aldolase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MMT-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'MMT-8; a set of 8 designated muscles tested bilaterally \\[potential score 0 - 150\\]', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'PRIMARY', 'title': 'CDASI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'The CDASI is a clinician-scored single page instrument that separately measures activity and damage in the skin of DM patients for use in clinical practice or clinical/therapeutic studies.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'PRIMARY', 'title': "Physician's Global Disease Activity VAS Worsening", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Physician\'s Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis).', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Extra-Muscular Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Extra-muscular activity (part of MDAAT; a combined tool that captures the physician\'s assessment of disease activity of various organ systems using a scale from 0 = "Not present in the last 4 weeks" to 4 = "New - in the last 4 weeks \\[compared to the previous 4 weeks\\]" and a VAS).', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Muscle Enzymes - Aldolase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Measurement of aldolase in blood', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Muscle Enzymes - Creatine Kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Measurement of creatine kinase in blood', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Muscle Enzymes - Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Measurement of alanine aminotransferase in blood', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Muscle Enzymes - Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Measurement of aspartate aminotransferase in blood', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Muscle Enzymes - Lactate Dehydrogenase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Measurement of lactate dehydrogenase in blood', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': '• Health Assessment Questionnaire (HAQ; a generic rather than a disease-specific instrument; comprised of 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 \\[without any difficulty\\] to 3 \\[unable to do\\]. For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8).', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'SF-36v2 Health Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Mean Change in TIS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Total Improvement Score', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Time to Clinically Important Deterioration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Time to clinically important deterioration', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Occurrence of all adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'TEEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety with occurrence of all thromboembolic events (TEEs)', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'HTRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety with occurrence of all hemolytic transfusion reactions (HTRs)', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Injection Site Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety by assessing local injection site reactions', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through blood pressure values', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through heart rate values', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through body temperature values', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through respiratory rate values', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 Weeks', 'description': 'The physical examination outcome will be analyzed based on changes from baseline as adverse events.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab sodium levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab potassium levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab glucose levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'ALAT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab ALAT levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'ASAT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab ASAT levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'LDH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab LDH levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab total bilirubin levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Blood Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab blood urea nitrogen levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urea levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab creatinine levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab albumin levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab hematocrit levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab hemoglobin levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Red Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab red blood cell count levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'White Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab white blood cell count levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab platelet levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Serum Haptoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab serum haptoglobin levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Plasma-Free Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab plasma-free hemoglobin', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': "Direct Coombs' Test", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': "Monitoring safety through Direct Coombs' test", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'D-dimers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through D-dimers test', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Serum IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab IgG levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Aldolase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab aldolase levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Creatine Kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab creatine kinase levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Pregnancy Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through pregnancy test', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine protein levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine glucose levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine pH levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine Nitrite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine nitrite levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine Ketones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine ketone levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine leukocyte levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine hemoglobin levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine bilirubin levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine Urobilinogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine urobilinogen levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Urine Hemosiderin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine hemosiderin levels', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'HIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through HIV testing', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Hepatitis B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through hepatitis B testing', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}, {'type': 'SECONDARY', 'title': 'Hepatitis C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'timeFrame': '32 weeks', 'description': 'Monitoring safety through hepatitis C testing', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prematurely. Due to the limited data available (only one patient enrolled and treated), efficacy and safety analyses were not performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%\n\nOctanorm: Octanorm 0.5g/kg/week'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Early study termination.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-16', 'size': 17387787, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-12T14:09', 'hasProtocol': True}, {'date': '2018-07-20', 'size': 1289747, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-12T14:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study complexity, low study recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2018-08-31', 'resultsFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-22', 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MMT-8', 'timeFrame': '32 weeks', 'description': 'MMT-8; a set of 8 designated muscles tested bilaterally \\[potential score 0 - 150\\]'}, {'measure': 'CDASI', 'timeFrame': '32 weeks', 'description': 'The CDASI is a clinician-scored single page instrument that separately measures activity and damage in the skin of DM patients for use in clinical practice or clinical/therapeutic studies.'}, {'measure': "Physician's Global Disease Activity VAS Worsening", 'timeFrame': '32 weeks', 'description': 'Physician\'s Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis).'}], 'secondaryOutcomes': [{'measure': 'Extra-Muscular Disease Activity', 'timeFrame': '32 weeks', 'description': 'Extra-muscular activity (part of MDAAT; a combined tool that captures the physician\'s assessment of disease activity of various organ systems using a scale from 0 = "Not present in the last 4 weeks" to 4 = "New - in the last 4 weeks \\[compared to the previous 4 weeks\\]" and a VAS).'}, {'measure': 'Muscle Enzymes - Aldolase', 'timeFrame': '32 weeks', 'description': 'Measurement of aldolase in blood'}, {'measure': 'Muscle Enzymes - Creatine Kinase', 'timeFrame': '32 weeks', 'description': 'Measurement of creatine kinase in blood'}, {'measure': 'Muscle Enzymes - Alanine Aminotransferase', 'timeFrame': '32 weeks', 'description': 'Measurement of alanine aminotransferase in blood'}, {'measure': 'Muscle Enzymes - Aspartate Aminotransferase', 'timeFrame': '32 weeks', 'description': 'Measurement of aspartate aminotransferase in blood'}, {'measure': 'Muscle Enzymes - Lactate Dehydrogenase', 'timeFrame': '32 weeks', 'description': 'Measurement of lactate dehydrogenase in blood'}, {'measure': 'Health Assessment Questionnaire', 'timeFrame': '32 weeks', 'description': '• Health Assessment Questionnaire (HAQ; a generic rather than a disease-specific instrument; comprised of 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 \\[without any difficulty\\] to 3 \\[unable to do\\]. For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8).'}, {'measure': 'SF-36v2 Health Survey', 'timeFrame': '32 weeks', 'description': 'The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.'}, {'measure': 'Mean Change in TIS', 'timeFrame': '32 weeks', 'description': 'Total Improvement Score'}, {'measure': 'Time to Clinically Important Deterioration', 'timeFrame': '32 weeks', 'description': 'Time to clinically important deterioration'}, {'measure': 'Adverse Events', 'timeFrame': '32 weeks', 'description': 'Occurrence of all adverse events'}, {'measure': 'TEEs', 'timeFrame': '32 weeks', 'description': 'Monitoring safety with occurrence of all thromboembolic events (TEEs)'}, {'measure': 'HTRs', 'timeFrame': '32 weeks', 'description': 'Monitoring safety with occurrence of all hemolytic transfusion reactions (HTRs)'}, {'measure': 'Injection Site Reactions', 'timeFrame': '32 weeks', 'description': 'Monitoring safety by assessing local injection site reactions'}, {'measure': 'Blood Pressure', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through blood pressure values'}, {'measure': 'Heart Rate', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through heart rate values'}, {'measure': 'Body Temperature', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through body temperature values'}, {'measure': 'Respiratory Rate', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through respiratory rate values'}, {'measure': 'Physical Examination', 'timeFrame': '32 Weeks', 'description': 'The physical examination outcome will be analyzed based on changes from baseline as adverse events.'}, {'measure': 'Sodium', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab sodium levels'}, {'measure': 'Potassium', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab potassium levels'}, {'measure': 'Glucose', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab glucose levels'}, {'measure': 'ALAT', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab ALAT levels'}, {'measure': 'ASAT', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab ASAT levels'}, {'measure': 'LDH', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab LDH levels'}, {'measure': 'Total Bilirubin', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab total bilirubin levels'}, {'measure': 'Blood Urea Nitrogen', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab blood urea nitrogen levels'}, {'measure': 'Urea', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urea levels'}, {'measure': 'Creatinine', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab creatinine levels'}, {'measure': 'Albumin', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab albumin levels'}, {'measure': 'Hematocrit', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab hematocrit levels'}, {'measure': 'Hemoglobin', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab hemoglobin levels'}, {'measure': 'Red Blood Cell Count', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab red blood cell count levels'}, {'measure': 'White Blood Cell Count', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab white blood cell count levels'}, {'measure': 'Platelets', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab platelet levels'}, {'measure': 'Serum Haptoglobin', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab serum haptoglobin levels'}, {'measure': 'Plasma-Free Hemoglobin', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab plasma-free hemoglobin'}, {'measure': "Direct Coombs' Test", 'timeFrame': '32 weeks', 'description': "Monitoring safety through Direct Coombs' test"}, {'measure': 'D-dimers', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through D-dimers test'}, {'measure': 'Serum IgG', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab IgG levels'}, {'measure': 'Aldolase', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab aldolase levels'}, {'measure': 'Creatine Kinase', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab creatine kinase levels'}, {'measure': 'Pregnancy Test', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through pregnancy test'}, {'measure': 'Urine Protein', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine protein levels'}, {'measure': 'Urine Glucose', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine glucose levels'}, {'measure': 'Urine pH', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine pH levels'}, {'measure': 'Urine Nitrite', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine nitrite levels'}, {'measure': 'Urine Ketones', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine ketone levels'}, {'measure': 'Urine Leukocytes', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine leukocyte levels'}, {'measure': 'Urine Hemoglobin', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine hemoglobin levels'}, {'measure': 'Urine Bilirubin', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine bilirubin levels'}, {'measure': 'Urine Urobilinogen', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine urobilinogen levels'}, {'measure': 'Urine Hemosiderin', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through lab urine hemosiderin levels'}, {'measure': 'HIV', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through HIV testing'}, {'measure': 'Hepatitis B', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through hepatitis B testing'}, {'measure': 'Hepatitis C', 'timeFrame': '32 weeks', 'description': 'Monitoring safety through hepatitis C testing'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatomyositis']}, 'descriptionModule': {'briefSummary': 'DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects with diagnosis of definite or probable DM according to the Bohan and Peter criteria.\n2. Subjects who have responded to IGIV treatment as assessed by the treating physician and being on a stable dose for at least 3 months on 2 g/kg bodyweight (+/- 10%).\n3. For subjects being on other medication(s) for the treatment of DM (immunosuppressants, corticosteroids): a) subject was on such medication(s) at the start of IGIV treatment in the first place, and b) received such medication(s) for at least 3 months prior to study enrolment and at a stable dose for at least 4 weeks prior to study enrolment at the maximally allowed conditions as per Table 2 (see section 4.2.1).\n4. MMT-8 score ≥144, with at least 3 other CSM to be normal or near normal as per the following criteria: Visual Analogue Scale \\[VAS\\] of patient global disease activity ≤2 cm, physician's global disease activity ≤2 cm, extra-muscular disease activity ≤2 cm; no muscle enzyme \\>4 times upper limit of normal due to myositis, Health Assessment Questionnaire \\[HAQ\\] ≤0.25.\n5. Males or females ≥ 18 to \\<80 years of age.\n6. Voluntarily given, fully informed written consent obtained from subject before any study-related procedures are conducted.\n7. Subject must be capable and willing to understand and comply with the relevant aspects of the study protocol.\n\nExclusion Criteria:\n\n1. Cancer-associated myositis, defined as the diagnosis of myositis within 2 years of the diagnosis of cancer (except basal or squamous cell skin cancer or carcinoma in situ of the cervix that has been excised and cured and at least 1 or 5 years, respectively, have passed since excision).\n2. Evidence of active malignant disease or malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors) or breast cancer diagnosed within the previous 10 years. Subjects \\>5 years (\\>10 years for breast cancer) of cancer diagnosis who have been treated and are in remission are allowed.\n3. Subjects with overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis or drug-induced myopathy.\n4. Subjects with immune-mediated necrotizing myopathy with absence of typical DM rash.\n5. Subjects with generalized, severe musculoskeletal conditions other than DM that prevent a sufficient assessment of the subject by the physician.\n6. Subjects who received blood or plasma-derived products (other than IGIV) or plasma exchange within the last 3 months before enrolment.\n7. Subjects with administration of permitted concomitant medications exceeding the maximally allowed conditions as per section 4.2.1.\n8. Subjects with administration of forbidden concomitant medications within the washout periods as defined in Table 3: see section 4.2.2.\n9. Subjects starting or planning to start a physical therapy-directed exercise regimen during the trial. Subjects on stable physical therapy for \\>4 weeks are allowed but the regimen should remain the same throughout the trial.\n10. Cardiac insufficiency (New York Heart Association III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease.\n11. Severe liver disease, with signs of ascites and hepatic encephalopathy.\n12. Severe kidney disease (as defined by estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73 m2).\n13. Known hepatitis B, hepatitis C or HIV infection.\n14. Subjects with a history of deep vein thrombosis within the last year prior to study enrolment or pulmonary embolism ever.\n15. Body mass index \\>40 kg/m2 and/or body weight \\>120 kg.\n16. Medical conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome).\n17. Known IgA deficiency with antibodies to IgA.\n18. History of hypersensitivity, anaphylaxis or severe systemic response to immunoglobulin, blood or plasma derived products or any component of octanorm 16.5% such as polysorbate 80 or to sodium chloride.\n19. Known blood hyperviscosity, or other hypercoagulable states.\n20. Subjects with a history of drug abuse within the past 5 years prior to study enrolment.\n21. Participating in another interventional clinical study with investigational treatment within 3 months prior to study enrolment. Subjects who participated in the Octagam 10% Dermatomyositis Study (GAM10-08) can be included.\n22. Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to apply an effective birth control method (as per protocol section 7.3.9 b) up to four weeks after the last IMP infusion received."}, 'identificationModule': {'nctId': 'NCT03686969', 'briefTitle': 'Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Octapharma'}, 'officialTitle': 'Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Dermatomyositis (SCGAM-02)', 'orgStudyIdInfo': {'id': 'SCGAM-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Octanorm', 'description': '0.5g/kg/week octanorm 16.5%', 'interventionNames': ['Drug: Octanorm']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Octanorm', 'type': 'DRUG', 'description': 'Octanorm 0.5g/kg/week', 'armGroupLabels': ['Octanorm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119992', 'city': 'Moscow', 'country': 'Russia', 'facility': 'I.M. SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY Rheumatology Department Of, Clinici Of Nephrology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Octapharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}