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NCT04567511 · ClinicalTrials.gov registry record · Phase 4
Hemlibra in Mild Hemophilia A
A Phase 4 study of Factor VIII Deficiency, Congenital, sponsored by Indiana Hemophilia &Thrombosis Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04567511 is a Phase 4 study of Factor VIII Deficiency, Congenital that is actively recruiting participants, run by Indiana Hemophilia &Thrombosis Center. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04567511, a Phase 4 study of Factor VIII Deficiency, Congenital, is actively recruiting participants, sponsored by Indiana Hemophilia &Thrombosis Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm, phase 4, prospective, open-label, United States single-center study to determine the hemostatic characteristics of Hemlibra (emicizumab) as measured by coagulation laboratory parameters in the mild hemophilia A male patient population with endogenous altered FVIII (baseline FVIII activity of \>5% to 30%). The safety and hemostatic efficacy of Hemlibra (emicizumab) in this patient population will be investigated. Secondary outcomes will assess changes in joint health and quality of life in treated patients.
Conditions Studied
Interventions
- DRUG Emicizumab
Study Locations (1)
Indiana
- Indiana Hemophila @Thrombosis Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-07-25 |
| Est. Completion | 2027-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04567511
The ClinicalTrials.gov registry entry for NCT04567511 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana Hemophilia &Thrombosis Center, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Factor VIII Deficiency, Congenital appearing as the primary indexed condition, and to 1 intervention - of which Emicizumab is the first listed.
NCT04567511 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT04567511 about?
NCT04567511 is a clinical study titled "Hemlibra in Mild Hemophilia A". This is a single arm, phase 4, prospective, open-label, United States single-center study to determine the hemostatic characteristics of Hemlibra (emicizumab) as measured by coagulation laboratory parameters in the mild hemophilia A male patient population with endogenous altered FVIII (baseline FVI...
What is the current status of trial NCT04567511?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2022-07-25. Estimated completion is 2027-07.
What conditions does trial NCT04567511 study?
This clinical trial studies the following conditions: Factor VIII Deficiency, Congenital.
What interventions are being tested in trial NCT04567511?
The interventions under investigation include: Emicizumab (DRUG).
Who is sponsoring clinical trial NCT04567511?
This trial is sponsored by Indiana Hemophilia &Thrombosis Center, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04567511 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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