Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-04-14 @ 9:53 AM
Study NCT ID:
NCT02418793
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacodynamic Profile (evaluate the pharmacodynamic response (FVIIa clotting activity, coagulation parameters) of single IV administration of escalating MOD-5014 doses)', 'timeFrame': '14 days', 'description': 'To evaluate the pharmacodynamic response (FVIIa clotting activity, coagulation parameters) of single IV administration of escalating MOD-5014 doses in hemophilic subjects with and without inhibitors.'}], 'primaryOutcomes': [{'measure': 'Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions', 'timeFrame': '30 days', 'description': 'To assess the acute safety and tolerability of single intravenous (IV) administration of escalating MOD-5014 doses in hemophilic subjects with and without inhibitors.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic Profile', 'timeFrame': '14 days', 'description': 'To evaluate the pharmacokinetic profile (MOD-5014 serum levels; Area Under the Curve (AUC); Cmax; Tmax; T1/2) of single IV administration of escalating MOD-5014 doses in hemophilic subjects with and without inhibitors.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hemophilia', 'Factor VII', 'Factor VIIa', 'Inhibitors', 'Long Acting'], 'conditions': ['Hemophilia A', 'Hemophilia B']}, 'descriptionModule': {'briefSummary': 'The purpose of the current Phase 1/2a single dose, dose-escalating study is to evaluate the acute safety, pharmacokinetics (PK) and pharmacodynamics (PD) properties of MOD-5014 in adult subjects with moderate/severe congenital hemophilia A or B. This will be a single-dose, open label, dose-escalating study. Each dose cohort will be concluded by a safety review, following which escalation to the next dose cohort will be approved.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of moderate or severe congenital Hemophilia A or B with or without inhibitors\n\nExclusion Criteria:\n\n* Diagnosis of any coagulation disorder other than Hemophilia A or B\n* Receipt of any immunomodulatory therapy within 3 months prior to screening, with the exception of Hepatitis C or HIV therapy\n* Have had, within one month prior to study drug administration, a major surgical procedure (e.g. orthopedic, abdominal) or have an elective surgery planned within the study period\n* Use of any anticoagulant for arterial/venous obstructions and/or atrial fibrillation within 7 days prior to first study drug administration\n* Malignancy within past 5 years (excluding non-melanoma skin cancer)'}, 'identificationModule': {'nctId': 'NCT02418793', 'briefTitle': 'A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B', 'organization': {'class': 'INDUSTRY', 'fullName': 'OPKO Health, Inc.'}, 'officialTitle': 'A Phase 1/2a, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) Profile of a Long Acting Recombinant FVIIa (MOD-5014) in Adult Men With Hemophilia A or B', 'orgStudyIdInfo': {'id': 'CP-5-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Cohort 1', 'description': 'Lowest MOD-5014 dose tested in the study', 'interventionNames': ['Drug: MOD-5014']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Cohort 2', 'description': 'MOD-5014 Dose cohort 2', 'interventionNames': ['Drug: MOD-5014']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Cohort 3', 'description': 'MOD-5014 Dose cohort 3', 'interventionNames': ['Drug: MOD-5014']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Cohort 4', 'description': 'MOD-5014 Dose cohort 4', 'interventionNames': ['Drug: MOD-5014']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Cohort 5', 'description': 'MOD-5014 Dose cohort 5', 'interventionNames': ['Drug: MOD-5014']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Cohort 6', 'description': 'Highest MOD-5014 dose tested in the study', 'interventionNames': ['Drug: MOD-5014']}], 'interventions': [{'name': 'MOD-5014', 'type': 'DRUG', 'description': 'Long Acting Factor VIIa', 'armGroupLabels': ['Dose Cohort 1', 'Dose Cohort 2', 'Dose Cohort 3', 'Dose Cohort 4', 'Dose Cohort 5', 'Dose Cohort 6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Orthopaedic Hemophilia Treatment Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Bleeding & Clotting Disorders Institute', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hemophilia & Thrombosis Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian Shadyside', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Gulf States Hemophilia and Thrombophilia Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Guy Ben-Bashat', 'role': 'STUDY_DIRECTOR', 'affiliation': 'OPKO Health, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OPKO Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}