Severe Hemophilia A study: MARSTACIMAB
Official title A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A.
ClinicalTrials.gov ID: NCT06703606
What this study is testing
What is Marstacimab?
This is an investigational once-weekly injectable medicine being studied for people with severe Hemophilia A who do not have inhibitors. It is designed to help the blood clot normally by replacing the missing clotting factor.
Also referred to as PF-06741086.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how safe marstacimab is, how the body handles it, and how well it works in people with severe hemophilia A who have no inhibitors.
- Who it's for
- Adults and teens 12‑74 years old with severe hemophilia A, no inhibitors, who have been on emicizumab for at least 6 months and weigh at least 35 kg.
- What's involved
- Participants receive weekly 150 mg subcutaneous injections of marstacimab for 4 months, starting at least 14 days after their last emicizumab dose. They keep using clotting factor for bleeding episodes as usual. The study drug is supplied by the sponsor.
- Time commitment
- The study lasts up to 6 months, with weekly visits for injections and monitoring. Optional extension may be available for those who wish to continue marstacimab if it is not yet available in their country.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 74, men only
You may be able to join if
- Male and 12 to \<75 years of age with a minimum body weight of 35 kg at the time of signing the informed consent.
- Diagnosis of severe hemophilia A (FVIII activity \<1%) without inhibitors.
- On emicizumab therapy at a standard clinical dose for ≥6 months.
You likely can't join if
- Previous or current treatment for or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may...
- Known hemostatic defect other than hemophilia A.
- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention...
- Platelet count \<100,000/μl or hemoglobin \<10 g/dL.
See the full eligibility criteria
- Male and 12 to \<75 years of age with a minimum body weight of 35 kg at the time of signing the informed consent.
- Diagnosis of severe hemophilia A (FVIII activity \<1%) without inhibitors.
- On emicizumab therapy at a standard clinical dose for ≥6 months.
- Previous or current treatment for or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease.
- 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...
- Known hemostatic defect other than hemophilia A.
- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- 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).
- Platelet count \<100,000/μl or hemoglobin \<10 g/dL.
- Clinically significant renal or hepatic function abnormality based on laboratory results at screening, or known kidney or liver disease.
- CD4 cell count ≤200/μl if HIV positive.
- 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.
- Known planned surgical procedure.
- Hypersensitivity or allergic reaction to hamster protein or other components of the study intervention.
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Greenville, North Carolina, United States
- Surat, Gujarat, India
- Mumbai, Maharashtra, India
- Bornova, İzmir, Turkey (Türkiye)
- Fatih, İ̇stanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 12 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Greenville, North Carolina, United States; Surat, Gujarat, India; Mumbai, Maharashtra, India; Bornova, İzmir, Turkey (Türkiye); Fatih, İ̇stanbul, Turkey (Türkiye). Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.