Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-28 @ 10:30 AM
Study NCT ID:
NCT01706159
Status:
TERMINATED
Last Update Posted:
2014-10-02
First Post:
2012-10-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521905', 'term': 'recombinant factor XIII-A2'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Novo Nordisk reserves the right to prior review of such publications and to ask for delay of publication of individual site results until after the primary manuscript is accepted for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The trial was terminated earlier than planned as the hypothesis of a correlation between low levels of FXIII and disease activity of UC could not be confirmed.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events reported by the investigator from the first trial-related activity after the subject is exposed to the trial drug until the end of trial visit (Week 10).', 'description': 'Safety analysis set was identical to the FAS which included all randomised and treated subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'rFXIII', 'description': 'Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.', 'otherNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.', 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Endoscopic Remission Defined as a Modified Baron Score of 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rFXIII', 'description': 'Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '90', 'paramValue': '0.16', 'ciLowerLimit': '0.01', 'ciUpperLimit': '3.05', 'pValueComment': 'p-value was not adjusted for multiple comparisons.', 'groupDescription': "A sample size of 90 subjects, with a 2:1 (active:placebo) randomization ratio, would ensure 80% power to detect a difference between active treatment and placebo at Week 8 with a 2-sided significance level of 10% based on a Fisher's exact test.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At week 8', 'description': 'The primary endpoint was the binary variable ("responder" vs. "non-responder") where "responders" were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as "non-responders".', 'unitOfMeasure': 'Subjects', 'populationDescription': 'Full analysis set (FAS) included all randomised and treated subjects.'}, {'type': 'SECONDARY', 'title': 'Remission (Clinical and Endoscopic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rFXIII', 'description': 'Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1).', 'unitOfMeasure': 'Subjects', 'populationDescription': 'Full analysis set (FAS) included all randomised and treated subjects. Two subjects in the rFXIII group had no UC-DAI score at any visit, including baseline and they were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rFXIII', 'description': 'Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.'}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Mild adverse events', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fatal adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to 10', 'description': 'Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period.', 'unitOfMeasure': 'events', 'populationDescription': 'Safety analysis set included all randomised and treated subjects.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of rFXIII', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rFXIII', 'description': 'Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.'}], 'timeFrame': 'Samples were collected before and up to 72 hours after the first dose of rFXIII.', 'description': 'The volume of plasma cleared of the drug per unit time.', 'populationDescription': 'It was not possible to obtain credible single dose pharmakokinetics (PK) for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of rFXIII', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rFXIII', 'description': 'Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.'}], 'timeFrame': 'Samples were collected before and up to 72 hours after the first dose of rFXIII.', 'description': 'The peak plasma concentration of the drug after dose administration.', 'populationDescription': 'It was not possible to obtain credible single dose PK for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'rFXIII', 'description': 'Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Exposed', 'achievements': [{'comment': 'One subject was not exposed to rFXIII.', 'groupId': 'FG000', 'numSubjects': '13'}, {'comment': 'One subject was not exposed to placebo.', 'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Completers (With Baron Score at Week 8)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted at 12 sites in 6 countries as follows: Bulgaria (4 sites), Denmark (1 site), Hungary (1 site), Poland (4 sites), Russian Federation (1 site) and Ukraine (1 site).', 'preAssignmentDetails': 'No pre-assignments were given for this trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'rFXIII', 'description': 'Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '15.4', 'groupId': 'BG001'}, {'value': '39.2', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Whites', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '25.6', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '24.8', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The demographics and baseline characteristics are presented for the Full analysis set (FAS) which included all randomised and treated subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Trial screening data did not support the medical hypothesis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'dispFirstSubmitDate': '2013-11-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-22', 'studyFirstSubmitDate': '2012-10-09', 'dispFirstSubmitQcDate': '2013-11-07', 'resultsFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2012-10-10', 'dispFirstPostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-10', 'studyFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopic Remission Defined as a Modified Baron Score of 0', 'timeFrame': 'At week 8', 'description': 'The primary endpoint was the binary variable ("responder" vs. "non-responder") where "responders" were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as "non-responders".'}], 'secondaryOutcomes': [{'measure': 'Remission (Clinical and Endoscopic)', 'timeFrame': 'At Week 8', 'description': 'Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1).'}, {'measure': 'Number of Adverse Events (AEs)', 'timeFrame': 'Week 0 to 10', 'description': 'Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period.'}, {'measure': 'Clearance (CL) of rFXIII', 'timeFrame': 'Samples were collected before and up to 72 hours after the first dose of rFXIII.', 'description': 'The volume of plasma cleared of the drug per unit time.'}, {'measure': 'Maximum Concentration (Cmax) of rFXIII', 'timeFrame': 'Samples were collected before and up to 72 hours after the first dose of rFXIII.', 'description': 'The peak plasma concentration of the drug after dose administration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening\n* Currently receiving oral aminosalicylates at approved doses of at least 2g/day for at least 6 weeks. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)\n\nExclusion Criteria:\n\n* Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as less than 15 cm from the anal verge)\n* Requiring hospitalisation for current episode of severe UC\n* Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)\n* Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g. infliximab, adalimumab)\n* Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (Visit 2)\n* Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (Visit 2)\n* Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (Visit 1)\n* Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)\n* Currently receiving total parenteral nutrition'}, 'identificationModule': {'nctId': 'NCT01706159', 'briefTitle': 'A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'NN8717-3946'}, 'secondaryIdInfos': [{'id': '2011-001568-22', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1120-3824', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rFXIII', 'interventionNames': ['Drug: catridecacog']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'catridecacog', 'type': 'DRUG', 'otherNames': ['recombinant factor XIII'], 'description': 'Catridecacog (recombinant factor XIII, rFXIII) will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week at a dose of 35 IU/kg', 'armGroupLabels': ['rFXIII']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7002', 'city': 'Rousse', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': 'H5600', 'city': 'Békéscsaba', 'country': 'Hungary', 'geoPoint': {'lat': 46.68333, 'lon': 21.1}}, {'zip': '90-153', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '60316', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '61000', 'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}