A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A.

StatusRecruiting
PhasePhase 1
SponsorPfizer
Started

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Record History

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  1. Minor Trial sites expanded: 7 → 10 locations
    • Eligibility criteria expanded, about 15 words
    • Study description revised
  2. Minor Trial sites expanded: 4 → 7 locationsv6
  3. Minor Study sites: 1 to 4v5
  4. Notable Enrollment target: 10 to 15v4 Show 4 more changesShow less
    • Primary completion date: May 11, 2027 to May 5, 2027
    • Study completion date: May 23, 2031 to May 5, 2027
    • Study description expanded, about 58 words
    • Eligibility criteria shortened, about 2 words
  5. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Jun 3, 2026 to May 11, 2027
    • Study sites: 0 to 1
    • Study completion date: Jun 3, 2026 to May 23, 2031
    • Start date changed from estimate of Apr 23, 2025 to May 13, 2025
  6. Notable Enrollment target: 15 to 10
    • Primary and study completion dates: Jul 25, 2025 to Jun 3, 2026
    • Start date: Dec 24, 2024 to Apr 23, 2025
    v2
  7. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
438 trials monitored
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241 trials monitored
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The purpose of the study is to learn about safety, how the body processes marstacimab and how it works in patients with severe hemophilia A without inhibitors. Hemophilia A is rare bleeding disorder where the blood doesn't clot normally. This causes a person to bleed a lot, even from a small cut. These patients who are on emicizumab medicine for routine prophylaxis for at least 6 months, and desire to switch to marstacimab medicine. Inhibitors are antibodies that the immune system develops because it sees the infused clotting factor as a foreign substance that needs to be destroyed. Antibodies are proteins that eat up the activated factor before it has time to stop the bleeding. Prophylaxis are preventive medicines. This study is seeking for participants: * with severe Hemophilia A withouth inhibitors who are on emicizumab treatment for at least 6 months. * must be 12 to less than 75 years old * must have a body weight of at least 35 kilograms. The results from this study will serve as a guide to doctors and their hemophilia A patients who will change their medicines in the real-world clinical setting. Patients who can take part in the study will receive marstacimab medicine as weekly injections under the skin of 150 milligrams for 4 months. Study treatment with marstacimab will be initiated no earlier than 14 days after last dose of emicizumab. The study can last up to 6 months. The sponsor will provide marstacimab. Patients will continue their usual treatment with the infused clotting factor for their bleeds when taking part in the study. Roll-over into an optional study treatment extension period will be available to participants who wish to continue prophylaxis with marstacimab in countries where it is not commercially available.
Trial Details
NCT Number NCT06703606
Lead Sponsor Pfizer
Conditions
(from sponsor)
Severe Hemophilia A
Related terms Hemophilia A
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov