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NCT03587116 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 212
- Enrollment target
NCT03587116: Completed Phase 3 study, sponsored by Pfizer.
NCT03587116 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 212 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03587116, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 212 participants
- Enrollment target
Study Summary
To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study. To establish baseline prospective efficacy data of current FVIII prophylaxis replacement therapy in the usual care setting of hemophilia A subjects, who are negative for nAb to AAV6, prior to the Phase 3 gene therapy study. The enrollment for hemophilia A participants is completed. At this time participants are only being enrolled for hemophilia B cohort.
Primary Outcome
ABR per participant was calculated as number of bleeds over number of days from baseline visit (Day 1 of the study) to end of study multiplication(\*)365.25 days. All bleeds included treated and untreated bleeds. A treated bleed was defined as an event necessitating administration of coagulation factor within 72 hours of signs or symptoms of bleeding. An untreated bleed was defined as an event not necessitating administration of coagulation factor within 72 hours of signs or symptoms of bleeding
Interventions
- DRUG Standard of Care FVIII Replacement therapy
- DRUG Standard of Care FIX Replacement therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2018-07-26 |
| Est. Completion | 2024-12-13 |
| Phase | Phase 3 |
What the finished NCT03587116 record still lists
NCT03587116 is an interventional study that assigns participants to a tested intervention. The registered 212 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 (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care FVIII Replacement therapy is the first listed.
NCT03587116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03587116 about?
NCT03587116 is a clinical study titled "A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)". To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study. To establish baseline prospective efficacy data of current FVIII prop...
What is the current status of trial NCT03587116?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 212 participants. The study started on 2018-07-26. Estimated completion is 2024-12-13.
What interventions are being tested in trial NCT03587116?
The interventions under investigation include: Standard of Care FVIII Replacement therapy (DRUG), Standard of Care FIX Replacement therapy (DRUG).
Who is sponsoring clinical trial NCT03587116?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03587116's enrollment target sits among peer trials
212 1335th of 2000 higher than 664 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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