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NCT01712438 · ClinicalTrials.gov registry record · Phase 3
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
A Phase 3 study, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 110
- Enrollment target
NCT01712438: Completed Phase 3 study, sponsored by Octapharma.
NCT01712438 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 110 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01712438, a Phase 3 study, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 110 participants
- Enrollment target
Study Summary
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.
Primary Outcome
The number of patients developing FVIII inhibitors was observed during the observation period by assessing inhibitor development using the modified Bethesda assay (Nijmegen modification). The definitions for thresholds were ≥0.6 to \<5 BU/mL for a "low titre" inhibitor and ≥5 BU/mL for a "high-titre" inhibitor.
Interventions
- BIOLOGICAL Human cl rhFVIII
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2013-02 |
| Est. Completion | 2019-12-20 |
| Phase | Phase 3 |
What the finished NCT01712438 record still lists
NCT01712438 is an interventional study that assigns participants to a tested intervention. The registered 110 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 (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Human cl rhFVIII is the first listed.
NCT01712438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01712438 about?
NCT01712438 is a clinical study titled "Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients". Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.
What is the current status of trial NCT01712438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2013-02. Estimated completion is 2019-12-20.
What interventions are being tested in trial NCT01712438?
The interventions under investigation include: Human cl rhFVIII (BIOLOGICAL).
Who is sponsoring clinical trial NCT01712438?
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 NCT01712438's enrollment target sits among peer trials
110 1657th of 2000 higher than 337 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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