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NCT04684940 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec in Hemophilia A With Active or Prior Inhibitors
A Phase 1 study of Hemophilia A With Inhibitor and Hemophilia A With Anti Factor VIII, sponsored by BioMarin Pharmaceutical.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 9
- Study locations
NCT04684940 is a Phase 1 study of Hemophilia A With Inhibitor and Hemophilia A With Anti Factor VIII that is active but no longer recruiting, run by BioMarin Pharmaceutical. The registered enrollment target is 10 participants. The trial reports 9 study locations across 2 states.
The verdict
NCT04684940, a Phase 1 study of Hemophilia A With Inhibitor and Hemophilia A With Anti Factor VIII, is active but no longer recruiting, sponsored by BioMarin Pharmaceutical.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 9
- Study locations
Study Summary
This Phase I/II clinical study will evaluate the safety and efficacy of valoctocogene roxaparvovec in patients with severe haemophilia A and inhibitors to FVIII. Part A of the study will involve subjects who have active inhibitors to FVIII, and Part B involving subjects with a prior history of inhibitors.
Conditions Studied
Interventions
- BIOLOGICAL Valoctocogene roxaparvovec
Study Locations (9)
Other
- Hemocentro Da UNICAMP - Campinas
- Arthur De Siqueira Cavalcanti Hematology State Institute - Rio de Janeiro
- Chaim Sheba Medical Center - Ramat Gan
- Kyung Hee University Hospital at Gangdong - Seoul
- Kaohsiung Medical University - Chung-Ho Memorial Hospital - Kaohsiung City
- Taichung Veterans General Hospital - Taichung
- National Taiwan University Hospital - Taipei
- Ege University School of Medicine - Izmir
California
- Children's Hospital Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2029-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04684940
The ClinicalTrials.gov registry entry for NCT04684940 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hemophilia A With Inhibitor appearing as the primary indexed condition, and to 1 intervention - of which Valoctocogene roxaparvovec is the first listed.
NCT04684940 reports 9 study locations spanning 2 distinct geographic areas - top geographies include Other, California.
Frequently Asked Questions
What is clinical trial NCT04684940 about?
NCT04684940 is a clinical study titled "Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec in Hemophilia A With Active or Prior Inhibitors". This Phase I/II clinical study will evaluate the safety and efficacy of valoctocogene roxaparvovec in patients with severe haemophilia A and inhibitors to FVIII. Part A of the study will involve subjects who have active inhibitors to FVIII, and Part B involving subjects with a prior history of inhib...
What is the current status of trial NCT04684940?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-12-10. Estimated completion is 2029-04.
What conditions does trial NCT04684940 study?
This clinical trial studies the following conditions: Hemophilia A With Inhibitor, Hemophilia A With Anti Factor VIII.
What interventions are being tested in trial NCT04684940?
The interventions under investigation include: Valoctocogene roxaparvovec (BIOLOGICAL).
Who is sponsoring clinical trial NCT04684940?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04684940 being conducted?
This trial has 9 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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