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NCT01405742 · ClinicalTrials.gov registry record · Phase 3
Hemophilia Adult Prophylaxis Study: Factor VIII in Severe Hemophilia A
A Phase 3 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT01405742: Clinical Trial Phase 3 study, sponsored by University of Pittsburgh.
NCT01405742 is a Phase 3 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01405742, a Phase 3 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this pilot R34 trial is to determine the feasibility of a large single dose Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly recombinant factor VIII. Efficacy will measured by bleeding frequency, factor usage, joint range of motion, cost, quality-of-life, F.VIII level, and inter-dose hypocoagulability by thrombin generation. Safety will be measured by inhibitor formation and bleeding events unresponsive to up to two rescue doses.
Primary Outcome
The primary outcome was bleed frequency. The data were total number of events for each Arm, and not per-participant.
Interventions
- DRUG rF.VIII
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
Why NCT01405742 stopped before completion
NCT01405742 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which rF.VIII is the first listed.
NCT01405742 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01405742 about?
NCT01405742 is a clinical study titled "Hemophilia Adult Prophylaxis Study: Factor VIII in Severe Hemophilia A". The purpose of this pilot R34 trial is to determine the feasibility of a large single dose Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly recombinant factor VIII. Efficacy will measured by bleeding frequency, factor usage, joint range of motion, cost, qualit...
What is the current status of trial NCT01405742?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2012-07. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01405742?
The interventions under investigation include: rF.VIII (DRUG).
Who is sponsoring clinical trial NCT01405742?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01405742's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 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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