Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT03427060
Status:
COMPLETED
Last Update Posted:
2025-05-04
First Post:
2018-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006457', 'term': 'Hemoglobinuria, Paroxysmal'}], 'ancestors': [{'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'miles.nunn@akaritx.com', 'phone': '+44 208 004 0261', 'title': 'Chief Scientific Officer', 'organization': 'Akari Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "All adverse events were collected from the time of informed consent until completion of patient's study participation. From Screening to Day 186", 'eventGroups': [{'id': 'EG000', 'title': 'Coversin Treatment. Ablation Dose: Day 1. 60 mg and 30 mg (12 Hours Apart)', 'description': 'This is an open label, non-comparator study.\n\nPatients were to receive coversin at ablation, initiation and maintenance doses:\n\n* Ablation (Day 1): 60 mg and 30 mg (12 hours apart)\n* Initiation (Day 2 - 28): 22.5 mg twice a day\n* Maintenance (Day 29 - 180): 45 mg once daily', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Coversin Treatment. Initiation Dose: Days 2 - 28. 22.5 mg Twice a Day (12 Hours Apart)', 'description': 'This is an open label, non-comparator study.\n\nPatients were to receive coversin at ablation, initiation and maintenance doses:\n\n* Ablation (Day 1): 60 mg and 30 mg (12 hours apart)\n* Initiation (Day 2 - 28): 22.5 mg twice a day\n* Maintenance (Day 29 - 180): 45 mg once daily', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Coversin Treatment. Maintenance Dose: Days 29 - 180. 45 mg Once Daily', 'description': 'This is an open label, non-comparator study.\n\nPatients were to receive coversin at ablation, initiation and maintenance doses:\n\n* Ablation (Day 1): 60 mg and 30 mg (12 hours apart)\n* Initiation (Day 2 - 28): 22.5 mg twice a day\n* Maintenance (Day 29 - 180): 45 mg once daily', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Device related Infection', 'notes': 'Catheter-related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measurement of Serum Lactate Dehydrogenase (LDH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coversin Treatment', 'description': 'This is an open label, non-comparator study.\n\nPatients were to receive coversin at ablation, initiation and maintenance doses:\n\n* Ablation (Day 1): 60 mg and 30 mg (12 hours apart)\n* Initiation (Day 2 - 28): 22.5 mg twice a day\n* Maintenance (Day 29 - 180): 45 mg once daily'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '2913', 'groupId': 'OG000'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '3056', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '1453', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '564', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '368', 'groupId': 'OG000'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '329', 'groupId': 'OG000'}]}]}, {'title': 'Day 36', 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}]}]}, {'title': 'Day 43', 'categories': [{'measurements': [{'value': '555', 'groupId': 'OG000'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '394', 'groupId': 'OG000'}]}]}, {'title': 'Day 120', 'categories': [{'measurements': [{'value': '352', 'groupId': 'OG000'}]}]}, {'title': 'Day 150', 'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}]}]}, {'title': 'Day 183', 'categories': [{'measurements': [{'value': '906', 'groupId': 'OG000'}]}]}, {'title': 'Day 184', 'categories': [{'measurements': [{'value': '882', 'groupId': 'OG000'}]}]}, {'title': 'Day 186', 'categories': [{'measurements': [{'value': '612', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 186', 'description': 'Measurement of serum lactate dehydrogenase (LDH)', 'unitOfMeasure': 'U/L', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Haemoglobin (Hb) Compared to Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coversin Treatment', 'description': 'This is an open label, non-comparator study.\n\nPatients were to receive coversin at ablation, initiation and maintenance doses:\n\n* Ablation (Day 1): 60 mg and 30 mg (12 hours apart)\n* Initiation (Day 2 - 28): 22.5 mg twice a day\n* Maintenance (Day 29 - 180): 45 mg once daily'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Day 36', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Day 43', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Day 120', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Day 150', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Day 186', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 186', 'description': 'Percentage change in the haemoglobin (Hb) value at each study visit compared to screening', 'unitOfMeasure': '%change in Hb value compare to screening', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Packed Red Blood Cells (PRBC) Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coversin Treatment', 'description': 'This is an open label, non-comparator study.\n\nPatients were to receive coversin at ablation, initiation and maintenance doses:\n\n* Ablation (Day 1): 60 mg and 30 mg (12 hours apart)\n* Initiation (Day 2 - 28): 22.5 mg twice a day\n* Maintenance (Day 29 - 180): 45 mg once daily'}], 'classes': [{'title': 'Day -35', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day -10', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Day 38', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 39', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 180', 'description': 'Number of units of packed red blood cells (PRBC) transfusions', 'unitOfMeasure': 'PRBC Units', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coversin Treatment', 'description': 'This is an open label, non-comparator study.\n\nPatients were to receive coversin at ablation, initiation and maintenance doses:\n\n* Ablation (Day 1): 60 mg and 30 mg (12 hours apart)\n* Initiation (Day 2 - 28): 22.5 mg twice a day\n* Maintenance (Day 29 - 180): 45 mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients with paroxysmal nocturnal hemoglobinuria (PNH) who had received eculizumab without apparent benefit and in whom it had been demonstrated that their serum was resistant to eculizumab at any concentration (due to complement C5 polymorphisms that prevent tight binding of eculizumab) were recruited from one medical center between May 2018 and February 2021.', 'preAssignmentDetails': 'There were no patients excluded from the study following enrolment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Coversin Treatment', 'description': 'This is an open label, non-comparator study.\n\nPatients were to receive coversin at ablation, initiation and maintenance doses:\n\n* Ablation (Day 1): 60 mg and 30 mg (12 hours apart)\n* Initiation (Day 2 - 28): 22.5 mg twice a day\n* Maintenance (Day 29 - 180): 45 mg once daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'cm'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'kg'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-12', 'size': 2287934, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-10T12:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2018-01-24', 'resultsFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-17', 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Serum Lactate Dehydrogenase (LDH)', 'timeFrame': 'Baseline to Day 186', 'description': 'Measurement of serum lactate dehydrogenase (LDH)'}], 'secondaryOutcomes': [{'measure': 'Percentage Change in Haemoglobin (Hb) Compared to Screening', 'timeFrame': 'Baseline to Day 186', 'description': 'Percentage change in the haemoglobin (Hb) value at each study visit compared to screening'}, {'measure': 'Number of Packed Red Blood Cells (PRBC) Transfusions', 'timeFrame': 'Baseline to Day 180', 'description': 'Number of units of packed red blood cells (PRBC) transfusions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paroxysmal Nocturnal Hemoglobinuria (PNH)']}, 'descriptionModule': {'briefSummary': 'Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.', 'detailedDescription': 'Coversin, a small protein complement C5 inhibitor which prevents the cleavage of C5 by C5 convertase into C5a and C5b, will be used in an open label, non-comparative clinical trial in patients with PNH and proven resistance to eculizumab due to C5 polymorphisms. Patients will be treated with Coversin by daily subcutaneous injection for 6 months in order to determine the safety and efficacy of the drug in these circumstances. If satisfactory control of the PNH is achieved, and at the discretion of the Principal Investigator (PI), patients will have the option of remaining on Coversin and being entered into the long term follow-up study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with known PNH.\n2. Aged 18 and above. No upper age limit.\n3. Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal.\n4. Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy.\n5. Resistance to eculizumab (Soliris®).\n6. Voluntary written informed consent.\n7. Willing to self-inject Coversin daily.\n8. Willing to receive appropriate prophylaxis against Neisseria infection.\n9. Willing to avoid prohibited medications for duration of study.\n\nExclusion Criteria:\n\n1. Subjects with body weight \\<50 kg (110 lb) or \\>100 kg (220 lb).\n2. Pregnancy or breast feeding (females).\n3. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).\n4. Unresolved Neisseria meningitidis infection.\n5. Patients who have not received adequate immunization against Neisseria meningitides.\n6. Impaired hepatic function.\n7. Patients with impaired renal function.\n8. Failure to satisfy the Principal Investigator (PI) of fitness to participate for any other reason.'}, 'identificationModule': {'nctId': 'NCT03427060', 'acronym': 'CONSENTII', 'briefTitle': 'Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms', 'organization': {'class': 'INDUSTRY', 'fullName': 'AKARI Therapeutics'}, 'officialTitle': 'CONSENT II: Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms', 'orgStudyIdInfo': {'id': 'AK585'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coversin treatment', 'description': 'Coversin - 22.5mg followed by 45mg for 6 months.', 'interventionNames': ['Drug: Coversin']}], 'interventions': [{'name': 'Coversin', 'type': 'DRUG', 'description': 'Coversin - 22.5mg followed by 45mg for 6 months.', 'armGroupLabels': ['Coversin treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AKARI Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}