Hemophilia A or B study: Marstacimab
Official title A Study to Assess the Safety of Marstacimab and How Well it Works in People With Mild to Moderate Hemophilia A or B Without Inhibitors
ClinicalTrials.gov ID: NCT07923981
What this study is testing
What is marstacimab?
marstacimab is an investigational medicine, given as a once-weekly injection under the skin, being studied as a potential treatment for hemophilia a or b.
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
- This is a study evaluating how well it works and how safe it is of marstacimab prophylaxis in approximately 95 male and female adolescents and adults aged 12 to \ 1% to ≤15% and a history of clinically significant bleeding despite prior treatment with either on-demand factor replacement therapy or routine factor prophylaxis.
- Phase 3: a large, late-stage study
- Time commitment: about 50 months
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
You may be able to join if
- Male or female, 12 to less than 75 years of age and weighing at least 35 kg.
- Moderate hemophilia A or B (factor VIII or factor IX activity ≥1% to ≤5%), or Mild hemophilia A or B (factor VIII or factor IX activity \>5% to ≤15%).
- Females with severe hemophilia A or B may be eligible on a case-by-case basis following discussion with sponsor.
- No history of factor VIII or factor IX inhibitors within the 5 years before screening.
- At least 12 months of medical records and/or bleeding diary data documenting hemophilia-related bleeding episodes and factor VIII or factor IX...
You likely can't join if
- Current evidence of a congenital or acquired thrombophilic disorder, including antithrombin III deficiency, Factor V Leiden mutation, prothrombin...
- Known coronary artery disease, history of venous or arterial thrombosis, or other clinically significant ischemic disease.
- Any bleeding disorder other than hemophilia A or hemophilia B.
- Any medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, could increase risk or interfere with study participation.
- Current use of bypassing agents, non-factor replacement therapies for hemophilia, or prior hemophilia gene therapy.
- Regular treatment with immunomodulatory medications.
See the full eligibility criteria
- Male or female, 12 to less than 75 years of age and weighing at least 35 kg.
- Moderate hemophilia A or B (factor VIII or factor IX activity ≥1% to ≤5%), or Mild hemophilia A or B (factor VIII or factor IX activity \>5% to ≤15%).
- Females with severe hemophilia A or B may be eligible on a case-by-case basis following discussion with sponsor.
- No history of factor VIII or factor IX inhibitors within the 5 years before screening.
- At least 12 months of medical records and/or bleeding diary data documenting hemophilia-related bleeding episodes and factor VIII or factor IX replacement therapy prior to screening.
- Participants receiving on-demand factor replacement therapy must have had at least 2 treated bleeding episodes during the 12 months before screening (surgical or procedural bleeds do not count).
- Participants receiving routine prophylactic factor replacement therapy must have received a stable prophylaxis regimen for at least 12 months with ≥80% compliance and at least 1 treated bleeding episode in the 12 months...
- Current evidence of a congenital or acquired thrombophilic disorder, including antithrombin III deficiency, Factor V Leiden mutation, prothrombin G20210A mutation, protein C deficiency, protein S deficiency, or...
- Known coronary artery disease, history of venous or arterial thrombosis, or other clinically significant ischemic disease.
- Any bleeding disorder other than hemophilia A or hemophilia B.
- Any medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, could increase risk or interfere with study participation.
- Current use of bypassing agents, non-factor replacement therapies for hemophilia, or prior hemophilia gene therapy.
- Regular treatment with immunomodulatory medications.
- Use of prohibited medications, including systemic antifibrinolytic agents, medications that increase bleeding risk, or certain nonsteroidal anti-inflammatory drugs (NSAIDs), as specified by the protocol.
- Use of estrogen-containing hormonal therapies (including contraceptives and HRTs) within 30 days before or during the study, or depot medroxyprogesterone acetate within 6 months before or during the study.
- Receipt of another investigational drug or vaccine within 30 days or 5 half-lives before study treatment (whichever is longer), or planned participation in another investigational study during this study.
- Significant renal or hepatic impairment or clinically significant laboratory abnormalities at screening.
- Platelet count \<100,000/μL, hemoglobin \<10 g/dL (with limited exceptions), fibrinogen below the lower limit of normal, or prolonged prothrombin time.
- CD4 count ≤200 cells/μL in participants with HIV infection.
- Clinically significant electrocardiogram abnormalities at screening.
- Planned surgical procedure during the study period.
- Known hypersensitivity to hamster protein or any component of the study treatment.
- Study site personnel, sponsor personnel directly involved in the conduct of the study, or their immediate family members.
The study team makes the final eligibility decision.
Where it is enrolling
- Flowood, Mississippi, United States
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 study runs about 50 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 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 Flowood, Mississippi, United States. 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.