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

Launched by PFIZER · Dec 1, 2021

Keywords

ClinConnect Summary

This clinical trial, called Study B7841007, is looking at a treatment called marstacimab for people with hemophilia A or hemophilia B, including those who may have developed inhibitors, which are antibodies that make traditional treatments less effective. The goal is to see how safely and effectively this treatment can be used over a longer period after participants have completed earlier studies. If you are between the ages of 1 and 75 and have severe hemophilia A or moderately severe to severe hemophilia B, and you participated in one of the previous studies without needing to end your participation early, you may be eligible to join.

Participants in this trial will receive marstacimab through an easy-to-use prefilled pen, although other options, like a syringe, will be available if needed. Throughout the study, participants will attend scheduled visits and undergo some tests to monitor their health. It’s important to note that there are specific health conditions that may prevent someone from joining the study, such as serious heart problems or unstable liver function. Overall, this trial aims to provide more information about how well marstacimab works in managing hemophilia over time.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • All participants will have a minimum body weight as defined by parent studies
• • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
• • Participants have successfully completed participation in parent studies, defined as did not require "Early Termination"
• 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 parent studies
• • 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