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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 October 2021 |
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Main ID: |
NCT03407651 |
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Date of registration:
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04/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B
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Scientific title:
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Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of a Daily Subcutaneous Treatment Regimen With Marzeptacog Alfa (Activated) for Bleeding Prophylaxis in Adult Subjects With Hemophilia A and B Subjects With an Inhibitor |
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Date of first enrolment:
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December 18, 2017 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03407651 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Armenia
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Georgia
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Lebanon
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Poland
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Russian Federation
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South Africa
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Contacts
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Name:
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Howard Levy, MD, PhD, MMM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Catalyst Biosciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Severe congenital hemophilia A or B with an inhibitor.
- History of frequent spontaneous bleeding episodes.
- Male, age 18 or older.
- Affirmation of informed consent with signature confirmation before any trial-related
activities.
Exclusion Criteria:
- Receiving prophylaxis treatment.
- Previous participation in a clinical trial evaluating a modified rFVIIa agent.
- Known positive antibody to FVII or FVIIa detected by central laboratory at screening.
- Have a coagulation disorder other than hemophilia A or B.
- Significant contraindication to participation.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hemophilia B With Inhibitor
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Hemophilia A With Inhibitor
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Intervention(s)
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Biological: Coagulation Factor VIIa variant
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Primary Outcome(s)
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Bleeding Episode Prevention Success
[Time Frame: Day 1 of final MarzAA dose level - Day 50]
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Secondary Outcome(s)
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Coagulation Assessment - Fibrinogen
[Time Frame: From date of pre-dose to 24 hours (Part 1a), 48 hours (Part 1b), or Day 50 (Part 2).]
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Occurrence of Clinical Thrombotic Event
[Time Frame: From date of first dose until date of first occurrence of clinical event, assessed up to treatment Day 50]
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Number of Events of Antibody Formation
[Time Frame: From time of first dose of MarzAA until date of first occurrence of clinical event, assessed up to treatment Day 50]
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Coagulation Assessment - Activated Partial Thromboplastin Time
[Time Frame: From date of pre-dose to 24 hours (Part 1a), 48 hours (Part 1b), to Day 50/end of study (Part 2)]
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Thrombogenicity Assessment
[Time Frame: From time of pre-dose of MarzAA at Day 1 until date of first occurrence of thrombotic event, assessed up to treatment Day 50.]
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Coagulation Assessment - Prothrombin Time
[Time Frame: From date of pre-dose to 24 hours (Part 1a), pre-dose to 48 hours (Part 1b), and pre-dose to Day 50 (Part 2)]
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Number of Events of an Antibody Response
[Time Frame: From time of first dose of MarzAA until date of first occurrence of clinical event, assessed up to treatment Day 50.]
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Occurrence of Breakthrough Bleeding
[Time Frame: From Day 5 of dose level until occurrence of event]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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