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NCT02172950 · ClinicalTrials.gov registry record · Phase 3
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
A Phase 3 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 246
- Enrollment target
NCT02172950: Completed Phase 3 study, sponsored by CSL Behring.
NCT02172950 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 246 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02172950, a Phase 3 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 246 participants
- Enrollment target
Study Summary
This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.
Interventions
- BIOLOGICAL rVIII-SingleChain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2014-10-13 |
| Est. Completion | 2021-01-19 |
| Phase | Phase 3 |
What the finished NCT02172950 record still lists
NCT02172950 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which rVIII-SingleChain is the first listed.
NCT02172950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02172950 about?
NCT02172950 is a clinical study titled "An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A". This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII produ...
What is the current status of trial NCT02172950?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 246 participants. The study started on 2014-10-13. Estimated completion is 2021-01-19.
What interventions are being tested in trial NCT02172950?
The interventions under investigation include: rVIII-SingleChain (BIOLOGICAL).
Who is sponsoring clinical trial NCT02172950?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02172950's enrollment target sits among peer trials
246 1267th of 2000 higher than 734 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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