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New treatment option for Hemophilia A
Official title Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
ClinicalTrials.gov ID: NCT05145127
What this study is testing
What is PF-06741086?
PF-06741086 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hemophilia a.
Also referred to as marstacimab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 74, men only
You may be able to join if
- 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"
You likely can't join if
- Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis (CTCAE Grade \>3), or ischemic disease (except...
- 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...
- For participants known to be HIV+, worsening disease status as determined by the Investigator clinical assessment and review of participant's most...
- Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic corticosteroids, rituximab)
See the full eligibility 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"
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- New Hyde Park, New York, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Mendoza, Argentina
- Melbourne, Victoria, Australia
- Vitória, Espírito Santo, Brazil
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
- Guangzhou, Guangdong, China
- Guiyang, Guizhou, China
- Wuhan, Hubei, China
- Nanchang, Jiangxi, China
- Tianjin, Tianjin Municipality, China
- Beijing, China
- Zagreb, Croatia
- Aarhus, Central Jutland, Denmark
- Paris, France
- Hong Kong, Hong Kong
- Ma Liu Shui, Hong Kong
+ 43 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 1 year to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; New Hyde Park, New York, United States; Philadelphia, Pennsylvania, United States; Seattle, Washington, United States; Mendoza, Argentina; Melbourne, Victoria, Australia and 57 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.