Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors

Phase 3

Recruiting

• Conditions: Bleeding tendency in patients with hemophilia A and B with and without inhibitors

• Registration Number: JPRN-jRCT2041220046
• Lead Sponsor: Kawai Norisuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 145

Inclusion Criteria

Inclusion Criteria:
*All participants will have a minimum body weight of 35 kg
*Participants have successfully completed participation in study B7841005, defined as did not require Early Termination from study B7841005

Exclusion Criteria

Exclusion Criteria:
*Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis (CTCAE Grade >3), or ischemic disease (except catheter-associated thrombosis)
*Abnormal renal function as defined by eGFR <30 mL.min/1.73 m(2)
*Known planned surgical procedure during the planned study period
*Unstable hepatic function as determined by the Investigator clinical assessment and review of the participant's most recent laboratory results, which would make the participant inappropriate for the study
*For participants known to be HIV+, worsening disease status as determined by the Investigator clinical assessment and review of participant's most recent laboratory results, to include recent locally available CD4 count (if available), which would make the participant inappropriate for the study
*Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic corticosteroids, rituximab)
*Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study
*Participation in other study involving investigational drug(s) or investigational vaccine(s) within 30 days or 5 half-lives prior to or during study participation, with the exception of participation in study B7841005
*Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the Investigator, and their respective family members

Study & Design

• Study Type: Interventional
• Study Design: Not specified