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NCT05611801 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B
A Phase 3 study of Hemophilia A and Hemophilia B, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05611801 is a Phase 3 study of Hemophilia A and Hemophilia B that is actively recruiting participants, run by Pfizer. The registered enrollment target is 100 participants, above the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 17 states.
The verdict
NCT05611801, a Phase 3 study of Hemophilia A and Hemophilia B, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called marstacimab) for the potential treatment of hemophilia in pediatric patients. This study will enroll pediatric participants from ages 1 to 17 years in a sequential manner. The study will open enrollment to adolescent participants aged 12 to 17 years first. Then children aged 6 to 11 years will be permitted to enroll. Lastly, children aged 1 to 5 years will be permitted to enroll. This study will enroll participants who: * have severe Hemophilia A or moderately severe to severe Hemophilia B (with or without inhibitors) * have accurate historical records documenting all factor VIII, factor IX, or bypass agent infusions and hemophilia bleed events for at least 1 year prior to entering the study * if a non-inhibitor patient, must be on a stable routine prophylaxis regimen with factor VIII or factor IX replacement products for at least 12 months prior to study entry * if an inhibitor patient, must be on an on-demand bypass treatment regimen during the 12 months prior to study entry All participants in this study will receive marstacimab to use prophylactically. Marstacimab will be given once a week as a subcutaneous (under the skin) shot. The first dose of marstacimab will be given at the study site by the study site staff. During the 12-month treatment period, weekly doses of marstacimab can be given at home, or if preferred, the doses may be given by the study site staff. To help us determine if the study medicine is safe and effective, we will compare participant experiences when they are taking the study medicine to a historical period when they were not. Researchers want to see if the study medicine works to prevent the bleeding episodes commonly experienced by patients with Hemophilia. Participants will be in this study for about 14 months (approximately 1 month in a Screening period, 12 months receiving treatment, and 1 month in a follow-up period) durin
Conditions Studied
Interventions
- DRUG marstacimab
Study Locations (20)
Other
- Arbesu Hematología - Mendoza
- Hôpital Universitaire Necker Enfants Malades - Paris
- Charité Campus Virchow-Klinikum - Berlin
Hubei
- Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology - Wuhan
- Tongji Hospital of Tongji Medical College of HUST/Pediatric Hematology Department Pharmacy - Wuhan
Utah
- Intermountain - Primary Children's Hospital - Salt Lake City
New South Wales
- Sydney Children's Hospital - Randwick
Victoria
- Royal Children's Hospital - Melbourne
Vienna
- Medizinische Universität Wien - Vienna
Espírito Santo
- HEMOES - Vitória
Alberta
- Stollery Children's Hospital - Edmonton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-12-09 |
| Est. Completion | 2028-09-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05611801
The ClinicalTrials.gov registry entry for NCT05611801 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target (12% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which marstacimab is the first listed.
NCT05611801 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Other, Hubei, Utah.
Frequently Asked Questions
What is clinical trial NCT05611801 about?
NCT05611801 is a clinical study titled "A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B". The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called marstacimab) for the potential treatment of hemophilia in pediatric patients. This study will enroll pediatric participants from ages 1 to 17 years in a sequential manner. The study will open e...
What is the current status of trial NCT05611801?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2022-12-09. Estimated completion is 2028-09-10.
What conditions does trial NCT05611801 study?
This clinical trial studies the following conditions: Hemophilia A, Hemophilia B.
What interventions are being tested in trial NCT05611801?
The interventions under investigation include: marstacimab (DRUG).
Who is sponsoring clinical trial NCT05611801?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05611801 being conducted?
This trial has 20 study locations across Utah, New South Wales, Victoria, Vienna, Espírito Santo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.