NCT06703606 A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A.
| NCT ID | NCT06703606 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pfizer |
| Condition | Severe Hemophilia A |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2027-05-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-05-13 with a primary completion date of 2027-05-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male and 12 to \<75 years of age with a minimum body weight of 35 kg at the time of signing the informed consent. 2. Diagnosis of severe hemophilia A (FVIII activity \<1%) without inhibitors. 3. On emicizumab therapy at a standard clinical dose for ≥6 months. Exclusion Criteria: 1. Previous or current treatment for or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease. 2. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 3. Known hemostatic defect other than hemophilia A. 4. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). 5. Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study. 6. Platelet count \<100,000/μl or hemoglobin \<10 g/dL. 7. Clinically significant renal or hepatic function abnormality based on laboratory results at screening, or known kidney or liver disease. 8. CD4 cell count ≤200/μl if HIV positive. 9. Screening 12-lead ECG that demonstrates clinically significant abnormalities that, in the opinion of the investigator, may affect participant safety or interpretation of study results. 10. Known planned surgical procedure. 11. Hypersensitivity or allergic reaction to hamster protein or other components of the study intervention. 12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor-delegate employees directly involved in the conduct of the study and their family members.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT06703606 clinical trial?
This trial is open to male participants only, aged 12 Years or older, up to 74 Years, studying Severe Hemophilia A. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06703606 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06703606 currently recruiting?
Yes, NCT06703606 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT06703606 trial being conducted?
This trial is being conducted at Los Angeles, United States, Greenville, United States, Greenville, United States, Surat, India and 3 additional locations.
Who is sponsoring the NCT06703606 clinical trial?
NCT06703606 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 15 participants.