MARSTACIMAB REAL-WORLD EVALUATION OF EFFECTIVENESS IN HEMOPHILIA: A UNITED STATES MEDICAL RECORD AND PARTICIPANT REPORTED OUTCOME STUDY (MARVL-US)
| Registry | NCT07859527 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | Pfizer (Industry) |
| Conditions | Hemophilia |
| Interventions | Marstacimab (Drug) |
| Dates | start 2026-10-05 (estimated), primary completion 2028-08-30 (estimated), completion 2028-08-30 (estimated), first posted 2026-10-05, last updated 2026-10-05 |
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The purpose of this non-interventional, observational, real-world study is to find out what are the real-world experiences of people living with hemophilia A or B\[OK1.1\] who start the study medicine (called marstacimab) in routine clinical practice. Hemophilia is a rare genetic condition where the blood does not clot normally, meaning people bleed longer than usual after an injury.
This study is seeking participants who are living with hemophilia A or B and:
* Have a medical record documenting hemophilia A or hemophilia B. A hematologist must have confirmed the diagnosis before they join the study.
* Are under current treatment with marstacimab or have a prescription to start the treatment with marstacimab
* Are 6 years of age or older and the recipient of medical care in the United States All participants in this study will receive their usual treatment for hemophilia A or hemophilia B Participants will take part in this study for 1 year. During this time, they will complete up to six surveys. These surveys will be given between enrollment and about one year after marstacimab is started.
Some participants in the study may be asked to take part in interviews. During these interviews they will be asked about their experience with hemophilia or marstacimab.
The study will provide information about how well the marstacimab treatment works. It will also assess treatment burden, and treatment preferences. This information will help to determine its benefit compared to existing treatment options. It will also help doctors make treatment decisions and optimize hemophilia care.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Real World Data participants | Drug: Marstacimab | This observational study is designed as a virtual-site study to take place in the United States (US), and will collect real-world data from participants' documented routine interactions with the healthcare system, surveys, and interviews. Participants will be recruited from US-based healthcare sites that care for people living with hemophilia, or through digital outreach |
Sex: All, ages: 6 Years to any
Medical record documentation of hematologist-confirmed diagnosis of hereditary factor VIII deficiency disease (Hemophilia A) or hereditary factor IX deficiency disease (Hemophilia B) prior to enrollment * Current treatment with marstacimab or documentation of a prescription to initiate marstacimab * Aged 6 or older at the time of consenting into the study * Receipt of medical care in the United States * Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally authorized representative) has been informed of all pertinent aspects of the study ○ If the participant is between the ages of 7 and 17, evidence of a personally signed and dated informed assent indicating that the participant has been informed of and assents to the study