Status:
TERMINATED
Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B
Lead Sponsor:
Catalyst Biosciences
Conditions:
Hemophilia A With Inhibitor
Hemophilia B With Inhibitor
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their sta...
Eligibility Criteria
Inclusion
- Diagnosis of congenital hemophilia A or B with inhibitors
- Male or Female, age 12 or older
- History of frequent bleeding episodes
- Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities
Exclusion
- Previous participation in a clinical trial evaluating a modified rFVIIa agent
- Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect
- Known hypersensitivity to trial or related product
- Known positive antibody to FVII or FVIIa detected by central lab at screening
- Have a coagulation disorder other than hemophilia A or B
- Be immunosuppressed
- Significant contraindication to participate
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04489537
Start Date
May 4 2021
End Date
December 1 2021
Last Update
December 17 2021
Active Locations (43)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
3
Hematology Center after Prof. R. Yeolyan
Yerevan, Armenia
4
JSC "K.Eristavi National Center of Experimental and Clinical Surgery"
Tbilisi, Georgia