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

RecruitingPhase 3Ages 1 Year - 74 YearsMalePfizer
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In plain words

What the trial is, and whether it could suit you

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 and from the Phase 3 Study B7841008. 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 Study B7841005 during which they will receive prophylaxis (defined as treatment by SC injection of marstacimab). Study B7841008: this is an ongoing Phase 3, open-label study in pediatric participants \<18 years of age with severe hemophilia A (FVIII Coagulation Factor Activity \<1%) or moderately severe to severe hemophilia B (FIX Coagu

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • PF-06741086
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Where

78 sites
University of Iowa
Iowa City, United States
Northwell Health HTC
New Hyde Park, United States
The Feinstein Institutes for Medical Research
Philadelphia, United States
Washington Institute for Coagulation d/b/a WACBD
Seattle, United States
Arbesu Hematología
Mendoza, Argentina
Royal Children's Hospital
Melbourne, Australia
HEMOES
Vitória, Brazil
Stollery Children's Hospital
Edmonton, Canada

…and 70 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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