Status:
COMPLETED
Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B
Lead Sponsor:
Catalyst Biosciences
Conditions:
Hemophilia A With Inhibitor
Hemophilia B With Inhibitor
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous \[SC\] treatment regimen with MarzAA for bleeding prophylaxis in 1...
Detailed Description
Multi-center, open-label Phase 2 study to evaluate the PK, bioavailability, PD, efficacy and safety of a daily SC treatment regimen with MarzAA for bleeding prophylaxis in adult subjects with hemophil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03407651
Start Date
December 18 2017
End Date
April 13 2019
Last Update
September 23 2021
Active Locations (9)
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1
Hematology Center after Prof. R. Yeolyan
Yerevan, Armenia
2
JSC "K.Eristavi National Center of Experimental and Clinical Surgery"
Tbilisi, Georgia
3
LTD M.Zodelava Hematology Centre
Tbilisi, Georgia
4
LTD Medinvest - Institute of Hematology and Transfusiology
Tbilisi, Georgia