Actively Recruiting

Phase 1
Age: 12Years - 74Years
MALE
NCT06703606

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

Led by Pfizer · Updated on 2026-03-30

15

Participants Needed

4

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 74Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 12 to less than 75 years with a body weight of at least 35 kg at consent
  • Diagnosis of severe Hemophilia A with FVIII activity less than 1% without inhibitors
  • On emicizumab therapy at a standard clinical dose for at least 6 months
Not Eligible

You will not qualify if you...

  • History or current treatment for coronary artery disease, venous or arterial thrombosis, or ischemic disease
  • Any medical or psychiatric condition, including recent or active suicidal ideation or behavior, or lab abnormalities increasing study risk
  • Known bleeding disorder other than Hemophilia A
  • Current use of prohibited medications or unwillingness/inability to use required concomitant medications
  • Recent use (within 30 days or 5 half-lives) of investigational products or participation in other investigational studies
  • Platelet count below 100,000/μl or hemoglobin below 10 g/dL
  • Significant kidney or liver dysfunction or disease
  • CD4 count 200/μl or less if HIV positive
  • ECG abnormalities deemed unsafe by investigator
  • Planned surgery
  • Allergy or hypersensitivity to hamster protein or study treatment components
  • Investigator site staff involved in the study and their family members, and sponsor employees involved in the study and their family members

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Orthopaedic Institute for Children/Orthopaedic Hemophilia Treatment Center

Los Angeles, California, United States, 90007

Actively Recruiting

2

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, India, 395002

Actively Recruiting

3

K J Somaiya Hospital & Research Centre

Mumbai, Maharashtra, India, 400022

Actively Recruiting

4

Ege University Faculty of Medicine Dean's Office

Bornova, İzmir, Turkey (Türkiye), 35100

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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