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NCT02256917 · ClinicalTrials.gov registry record · Phase 3
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
A Phase 3 study, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
NCT02256917: Completed Phase 3 study, sponsored by Octapharma.
NCT02256917 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 58 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02256917, a Phase 3 study, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
Study Summary
The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.
Primary Outcome
Total annualized bleeding rate (ABR) of individually tailored prophylaxis (GENA-21b) compared to historical bleeding rate in patients having received on-demand treatment (GENA-01) with Human-cl rhFVIII
Interventions
- BIOLOGICAL Human cl rhFVIII
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-09 |
| Phase | Phase 3 |
What the finished NCT02256917 record still lists
NCT02256917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Human cl rhFVIII is the first listed.
NCT02256917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02256917 about?
NCT02256917 is a clinical study titled "Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A". The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis,...
What is the current status of trial NCT02256917?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2015-05. Estimated completion is 2018-09.
What interventions are being tested in trial NCT02256917?
The interventions under investigation include: Human cl rhFVIII (BIOLOGICAL).
Who is sponsoring clinical trial NCT02256917?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02256917's enrollment target sits among peer trials
58 1825th of 2000 higher than 174 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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