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NCT03370913 · ClinicalTrials.gov registry record · Phase 3
Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients (BMN 270-301)
A Phase 3 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 3
- Development phase
- 144
- Enrollment target
NCT03370913 is a Phase 3 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 144 participants.
The verdict
NCT03370913, a Phase 3 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 144 participants
- Enrollment target
Study Summary
This Phase III clinical study will assess the impact of BMN 270 (compared to FVIII prophylaxis) on the number of bleeding episodes irrespective of exogenous FVIII replacement treatment in the efficacy evaluation period (EEP) (from Week 5 post-BMN 270 infusion (Study Day 33) or the end of FVIII prophylaxis plus the washout period (3 days for products of standard half-life or plasma-derived and 5 days for products of extended half-life), whichever is later, to last visit by the data cut-off for the 2-year analysis, hereafter referred to as "Post FVIII Prophylaxis to Last Visit"). The study will also assess the impact of BMN 270 (compared to FVIII prophylaxis) on: the number of bleeding episodes requiring exogenous FVIII treatment in "Post FVIII Prophylaxis to Last Visit", FVIII activity as measured by chromogenic sustrate assay at Week 104 following intravenous infusion of BMN 270, usage of exogenous FVIII replacement therapy in "Post FVIII Prophylaxis to Last Visit", health-related quality of life patient-reported outcomes at week 104 following intravenous infusion of BMN 270. The study will also evaluate the safety of the BMN 270.
Interventions
- BIOLOGICAL valoctocogene roxaparvovec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2024-11-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03370913
The ClinicalTrials.gov registry entry for NCT03370913 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 144 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 0 conditions, and to 1 intervention - of which valoctocogene roxaparvovec is the first listed.
NCT03370913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03370913 about?
NCT03370913 is a clinical study titled "Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients (BMN 270-301)". This Phase III clinical study will assess the impact of BMN 270 (compared to FVIII prophylaxis) on the number of bleeding episodes irrespective of exogenous FVIII replacement treatment in the efficacy evaluation period (EEP) (from Week 5 post-BMN 270 infusion (Study Day 33) or the end of FVIII proph...
What is the current status of trial NCT03370913?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2017-12-19. Estimated completion is 2024-11-20.
What interventions are being tested in trial NCT03370913?
The interventions under investigation include: valoctocogene roxaparvovec (BIOLOGICAL).
Who is sponsoring clinical trial NCT03370913?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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