Study of Marzeptacog Alfa (Activated) in Subjects with Hemophilia A or B
Phase 3
- Conditions
- Health Condition 1: D67- Hereditary factor IX deficiencyHealth Condition 2: D66- Hereditary factor VIII deficiency
- Registration Number
- CTRI/2021/02/031507
- Lead Sponsor
- Catalyst Biosciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Diagnosis of congenital hemophilia A or B with inhibitors
2. Male or Female, age 12 or older
3. History of frequent bleeding episodes
4. Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities
Exclusion Criteria
1. Previous participation in a clinical trial evaluating a modified rFVIIa agent
2. Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect
3. Known hypersensitivity to trial or related product
4.Known positive antibody to FVII or FVIIa detected by central lab at screening
5. Have a coagulation disorder other than hemophilia A or B
6. Be immunosuppressed
7. Significant contraindication to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bleeding episode treatment successTimepoint: 24 hours after the first administration of study drug
- Secondary Outcome Measures
Name Time Method 1)To cessation of bleeding <br/ ><br>2)To To assess the ability of MarzAA to achieve and maintain hemostasis <br/ ><br>3)To assess the number of doses and the cumulative dose <br/ ><br>4)To assess the percentage of bleeds with treatment <br/ ><br>5) To assess the use and amount of rescue therapy <br/ ><br>6)To assess the SC PopPK of MarzAATimepoint: Secondary outcome no. 4) at 24 hours