Long-term treatment with marstacimab for hemophilia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label extension study evaluates the long-term safety, tolerability, and efficacy of marstacimab, a prophylactic treatment, in participants with severe hemophilia A or B, including those with and without inhibitors. Participants must have previously completed parent studies without early termination. The study aims to provide ongoing treatment through subcutaneous injections of marstacimab, assessing its effectiveness over an extended period. The trial includes both adolescent and adult participants, as well as pediatric patients under 18 years of age.

Why it matters

Who can join: the full rules

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

Where it's running

• Northwell Health HTC
  New Hyde Park, New York, United States Recruiting
• The Feinstein Institutes for Medical Research
  Philadelphia, Pennsylvania, United States Recruiting
• Washington Institute for Coagulation d/b/a WACBD
  Seattle, Washington, United States Recruiting
• Arbesu Hematología
  Mendoza, Argentina Recruiting
• Royal Children's Hospital
  Melbourne, Victoria, Australia Recruiting
• Hemoes
  Vitória, Espírito Santo, Brazil Recruiting

+28 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing marstacimab for treating hemophilia in children

  This study is testing a new medication called marstacimab to see if it can help children with severe hemophilia control their bleeding and improve their health.

  Recruiting at 51 sites Phase 3 Pfizer · Salt Lake City, Utah and 62 other locations · NCT05611801

• SR604: a new treatment tested in adults with Hemophilia A/B or congenital Factor VII deficiency

  This study tests a single and multiple doses of SR604 to see if it is safe and effective for adults with Hemophilia A or B, with or without inhibitors, and for those with congenital Factor VII deficiency.

  Recruiting at 7 sites Phase 1/2 Shanghai RAAS Blood Products Co., Ltd. · Changsha and 8 other locations · NCT07644832

• ATHNdataset registry for people with bleeding and clotting disorders

  This registry collects health, treatment, and patient-reported information from people with bleeding and clotting disorders seen at ATHN-affiliated centers to help improve care and outcomes.

  Recruiting American Thrombosis and Hemostasis Network · Hickory, North Carolina · NCT06820515

• Is synovial proliferation in haemophilia joints active or inactive?

  This project will test whether ultrasound, MRI and elastography can tell if subclinical synovial proliferation in people with severe haemophilia is currently active so clinicians can treat earlier.

  Recruiting UMC Utrecht · Utrecht · NCT06809972

• Observational study of blood clotting and bleeding disorders in Chinese patients

  This study looks at blood clotting and bleeding problems in Chinese patients to see how common they are and what factors might affect them.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality and 4 other locations · NCT06727669

• Evaluating the safety and effects of SR604 in healthy individuals and those with Hemophilia A or B

  This study is testing a new drug called SR604 to see if it's safe and effective for healthy people and those with Hemophilia A or B.

  Recruiting at 8 sites Phase 1 Equilibra Bioscience LLC · Glendale, California and 9 other locations · NCT06349473

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.