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NCT02847637 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 152
- Enrollment target
NCT02847637: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02847637 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 152 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02847637, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 152 participants
- Enrollment target
Study Summary
This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics.
Primary Outcome
The number of treated bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was assessed using a negative binomial (NB) regression model, which accounts for different follow-up times, with the number of bleeds as a function of randomization and the time that each participant stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes the number of bleeds (\<9 or ≥9) in the last 24 weeks prior to study entry
Interventions
- DRUG Emicizumab
- DRUG Factor VIII (FVIII)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2016-09-27 |
| Est. Completion | 2022-05-12 |
| Phase | Phase 3 |
What the finished NCT02847637 record still lists
NCT02847637 is an interventional study that assigns participants to a tested intervention. The registered 152 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Emicizumab is the first listed.
NCT02847637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02847637 about?
NCT02847637 is a clinical study titled "A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors". This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emph...
What is the current status of trial NCT02847637?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2016-09-27. Estimated completion is 2022-05-12.
What interventions are being tested in trial NCT02847637?
The interventions under investigation include: Emicizumab (DRUG), Factor VIII (FVIII) (DRUG).
Who is sponsoring clinical trial NCT02847637?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02847637's enrollment target sits among peer trials
152 1513th of 2000 higher than 484 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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