Actively Recruiting

Phase 3

Age: 1Year - 17Years

MALE

ID05611801

An Open-Label Study of Marstacimab Prophylaxis Compared to Historical Treatment in Pediatric Males With Severe Hemophilia A or Moderate to Severe Hemophilia B

Led by Pfizer

Updated on 2026-05-07

100

Participants Needed

34

Research Sites

N/A

Total Duration

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What This Trial Is About

This research aims to learn about the safety and effects of marstacimab, a study medicine being evaluated for treating Hemophilia in pediatric patients. It focuses on children aged 1 to 17 years with severe Hemophilia A or moderate to severe Hemophilia B, including those with or without inhibitors. The study compares participant experiences on marstacimab with their past standard treatments to see if it helps prevent bleeding episodes common in Hemophilia.



All participants will receive weekly marstacimab injections under the skin. The first dose is administered at the study site, and subsequent doses during the 12-month treatment period can be given at home or the study site. The study enrolls participants in age groups sequentially, starting with adolescents 12-17 years, followed by children 6-11 years, and then 1-5 years. The full participation lasts about 14 months, including screening, treatment, and follow-up periods. Participants will visit the study site at least 10 times and have 6 scheduled phone calls every two months. Researchers will monitor bleeding rates, adverse events, immune reactions, and joint health, along with quality of life changes. Safety assessments cover the entire study period, including follow-up, to evaluate marstacimabs effects and tolerability in children with Hemophilia.

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Brief Title

A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients Wit

📌 An Open-Label Study Of Marstacimab Prophylaxis Compared To Historical Treatment In Pediatric Males With Severe Hemophilia A Or Moderate To Severe Hemophilia B (Godoy Cruz)
🏢 DecenTrialz
📍 Godoy Cruz