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NCT05500807 · ClinicalTrials.gov registry record · Phase 1
Emicizumab for Severe Von Willebrand Disease (VWD) and VWD/Hemophilia A
A Phase 1 study of Von Willebrand Disease, Type 3 and Concomitant VWD and Hemophilia, sponsored by Bleeding and Clotting Disorders Institute Peoria, Illinois.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 9
- Study locations
NCT05500807 is a Phase 1 study of Von Willebrand Disease, Type 3 and Concomitant VWD and Hemophilia that is actively recruiting participants, run by Bleeding and Clotting Disorders Institute Peoria, Illinois. The registered enrollment target is 40 participants. The trial reports 9 study locations across 6 states.
The verdict
NCT05500807, a Phase 1 study of Von Willebrand Disease, Type 3 and Concomitant VWD and Hemophilia, is actively recruiting participants, sponsored by Bleeding and Clotting Disorders Institute Peoria, Illinois.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 9
- Study locations
Study Summary
Von Willebrand Disease (VWD) is the most common inherited bleeding disorder affecting up to 0.1% of the population, is usually characterized by mucocutaneous bleeding, HMB, surgical bleeding or other hemostatic challenges. Severe bleeding events require VWF concentrates administered solely through intravenous access. Emicizumab (Hemlibra) is a monoclonal bispecific antibody developed to bind activated FIX and FX and mimic FVIII cofactor functionality. Hemlibra is administered via subcutaneous injection rather than intravenous infusion. The hypothesis of this study is that Emicizumab is safe and efficacious for prophylaxis in severe VWD and concomitant VWD/hemophilia patients.
Conditions Studied
Interventions
- DRUG Emicizumab
Study Locations (9)
California
- The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders (CIBD) - Orange
- Stanford University: Stanford Children's Health - Redwood City
Florida
- University of Miami - Miller School of Medicine - Coral Gables
- St. Joseph's Children's Hospital - Center for Bleeding and Clotting Disorders - Tampa
Michigan
- University of Michigan Medical School - Ann Arbor
- Central Michigan University: Children's Hospital of Michigan - Mount Pleasant
Illinois
- Bleeding and Clotting Disorders Institute (BCDI) - Peoria
Indiana
- Innovative Hematology, Inc. (IHI) - Indianapolis
Washington
- Washington Center for Bleeding Disorders - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05500807
The ClinicalTrials.gov registry entry for NCT05500807 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bleeding and Clotting Disorders Institute Peoria, Illinois, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Von Willebrand Disease, Type 3 appearing as the primary indexed condition, and to 1 intervention - of which Emicizumab is the first listed.
NCT05500807 reports 9 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT05500807 about?
NCT05500807 is a clinical study titled "Emicizumab for Severe Von Willebrand Disease (VWD) and VWD/Hemophilia A". Von Willebrand Disease (VWD) is the most common inherited bleeding disorder affecting up to 0.1% of the population, is usually characterized by mucocutaneous bleeding, HMB, surgical bleeding or other hemostatic challenges. Severe bleeding events require VWF concentrates administered solely through i...
What is the current status of trial NCT05500807?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-11-01. Estimated completion is 2027-06.
What conditions does trial NCT05500807 study?
This clinical trial studies the following conditions: Von Willebrand Disease, Type 3, Concomitant VWD and Hemophilia.
What interventions are being tested in trial NCT05500807?
The interventions under investigation include: Emicizumab (DRUG).
Who is sponsoring clinical trial NCT05500807?
This trial is sponsored by Bleeding and Clotting Disorders Institute Peoria, Illinois, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05500807 being conducted?
This trial has 9 study locations across California, Florida, Illinois, Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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