Brief Title
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Official Title
AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF MARSTACIMAB PROPHYLAXIS IN PARTICIPANTS WITH SEVERE HEMOPHILIA A AND B WITH OR WITHOUT INHIBITORS
Brief 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of subject reporting Adverse Events
Secondary Outcome
Annualized rate of bleeding episodes
Condition
Hemophilia A
Intervention
PF-06741086
Study Arms / Comparison Groups
PF-06741086
Description: 300 milligrams(mg) subcutaneous (sc) loading dose followed by 150 mg sq once weekly (qw). 300 mg sc qw is prescribed for participants who meet dose escalation criteria.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
145
Start Date
November 17, 2021
Completion Date
July 31, 2030
Primary Completion Date
July 31, 2030
Eligibility 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: - 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 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
Gender
Male
Ages
12 Years - 74 Years
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, 1-800-718-1021, [email protected]
Location Countries
Hong Kong
Location Countries
Hong Kong
Administrative Informations
NCT ID
NCT05145127
Organization ID
B7841007
Secondary IDs
PHASE 3 ANTI-TFPI OLE
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
May 2022