Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Hemophilia A and Hemophilia B, sponsored by Pfizer.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Derived for each subject for each period (historical and study treatment) by using the following formula: ABR = number of bleeds requiring treatments/ (days on treatment period / 365.25)
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 |
What NCT05611801 shows while recruiting
NCT05611801 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 89-participant average among 42 other Hemophilia A trials with a reported enrollment target (12% higher).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
Similar trials for Hemophilia A
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05611801's enrollment target sits among peer trials
100 13th of 42 higher than 30 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
RECRUITING · Phase 3
-
SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
RECRUITING · Phase 3
-
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
RECRUITING · Phase 3
-
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
ACTIVE NOT RECRUITING · Phase 3
-
Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI