Last updated 18 days ago
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
245 patients around the world
Available in Mexico
Pfizer
245Patients around the world
Requirements for the patient
To 74 Years
Male
Medical requirements
- All participants will have a minimum body weight of 35 kgParticipants have successfully completed participation in study B7841005, defined as did not require "Early Termination" from study B7841005
- Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis (CTCAE Grade >3), or ischemic disease (except catherter-associated thrombosis)Abnormal renal function as defined by eGFR <30 mL.min/1.73 m(2)Known planned surgical procedure during the planned study periodUnstable 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 studyFor 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 studyRegular, 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 studyParticipation 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 B7841005Investigator 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
SponsorPfizer
Study typeInterventional
Requirements
To 74 YearsMale
Unique study IDclinicaltrials.gov
NCT05145127
