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NCT01425723 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B
A Phase 3 study, sponsored by Bioverativ Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT01425723: Completed Phase 3 study, sponsored by Bioverativ Therapeutics.
NCT01425723 is a Phase 3 study that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 120 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01425723, a Phase 3 study, has completed, sponsored by Bioverativ Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B. The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.
Primary Outcome
An inhibitor test result greater than or equal to (\>=)0.6 Bethesda units per milliliter (BU/mL), confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Data was summarized by treatment regimen for participants from Study 998HB102 and by age cohort (\<6 years and 6 to \<12 years old) and treatment regimen for participants from Study 9HB02PED per planned analysis. Part
Interventions
- BIOLOGICAL rFIXFc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2011-12-08 |
| Est. Completion | 2017-10 |
| Phase | Phase 3 |
What the finished NCT01425723 record still lists
NCT01425723 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (84% lower).
The record links to 0 conditions, and to 1 intervention - of which rFIXFc is the first listed.
NCT01425723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01425723 about?
NCT01425723 is a clinical study titled "Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B". The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B. The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.
What is the current status of trial NCT01425723?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2011-12-08. Estimated completion is 2017-10.
What interventions are being tested in trial NCT01425723?
The interventions under investigation include: rFIXFc (BIOLOGICAL).
Who is sponsoring clinical trial NCT01425723?
This trial is sponsored by Bioverativ Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01425723's enrollment target sits among peer trials
120 1619th of 2000 higher than 361 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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