Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Status:
Recruiting
Trial end date:
2030-07-31
Target enrollment:
Participant gender:
Summary
Study B7841007 is an open-label extension study to assess the long-term safety, tolerability,
and efficacy of prophylaxis treatment with marstacimab in participants who did not require
"Early Termination" from the Phase 3 Study B7841005. Approximately 145 adolescent and adult
participants 12 to <75 years of age with severe hemophilia A or moderately severe to severe
hemophilia B (defined as FVIII activity <1% or FIX activity ≤2%, respectively) with or
without inhibitors are expected to be enrolled in this study during which they will receive
prophylaxis (defined as treatment by SC injection of marstacimab). The dosing regimen of
marstacimab is 150 mg SC once weekly.
All participants will be provided the PFP for administration of marstacimab in the study. Use
of the PFS will be permitted at the investigator's discretion for those participants who have
difficulty with administration of the PFP. Additionally, participants will be provided the
PFS for use in this study in countries where the PFS is anticipated to be the only
presentation available commercially. In addition, an optional, open-label, single arm,
substudy using the PFP will be administered to the first approximately 20 participants
rolling over from Study B7841005 who agree to participate in the substudy.