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

Conditions

• Severe Hemophilia A

Eligibility Criteria

Sex

MALE

Age

12 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• MARSTACIMAB — DRUG
  Marstacimab 150 mg administered subcutaneous (SC) once weekly (QW)

Study Details

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.

Key Dates

Start date

May 13, 2025

Status verified

Jun 2026

Primary completion

May 5, 2027

Completion

May 5, 2027

Study Design

Enrollment

15 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: MARSTACIMAB
  Marstacimab 150 mg subcutaneous (SC) once weekly (QW)

Primary Outcome Measure

Incidence of marstacimab-related adverse events (AEs) [ Time Frame: Approximately 178 days: from the time the participant provides informed consent, through and including a minimum of 28 calendar days after last dose of study treatment ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (3)

Find similar trials in Los Angeles, CA

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