Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

Phase 3

Terminated

• Conditions: Hemophilia B With Inhibitor; Hemophilia A With Inhibitor

• Registration Number: NCT04489537
• Lead Sponsor: Catalyst Biosciences

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 standard of care (SOC).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-28
• Study Start: 2021-05-04
• Primary Completion: 2021-11-15
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bleeding episode treatment success	24 hours after the first administration of study drug	Proportion of bleeding events treated with MarzAA achieving hemostatic efficacy based on a four-point scale according to the Investigator's assessment compared with standard of care.

Trial Locations

Locations (43)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Lombardi Comprehensive Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Hematology Center after Prof. R. Yeolyan; 🇦🇲 Yerevan, Armenia

JSC "K.Eristavi National Center of Experimental and Clinical Surgery"; 🇬🇪 Tbilisi, Georgia

Magyar Honvédség Egészségügyi Központ, Országos Haemophilia Központ; 🇭🇺 Budapest, Hungary

Nirmal Hospital; 🇮🇳 Gujrat, India

K.L.E.S Dr. Prabhakar Kore Hospital and Medical Research Centre; 🇮🇳 Karnad, India

Sanjay Gandhi Postgraduate Institute of Medical Sciences; 🇮🇳 Lucknow, India

K.J Somaiya Hospital and Research Centre; 🇮🇳 Mumbai, India

MCGM - Comprehensive Thalassemia Care, Pediatric Hematology-Oncology & BMT Centre; 🇮🇳 Mumbai, India

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