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NCT01486927 · ClinicalTrials.gov registry record · Phase 2
An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
A Phase 2 study of Hemophilia A, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
- 20
- Study locations
NCT01486927: Completed Phase 2 study of Hemophilia A, sponsored by CSL Behring.
NCT01486927 is a Phase 2 study of Hemophilia A that has completed, run by CSL Behring. The registered enrollment target is 175 participants, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01486927, a Phase 2 study of Hemophilia A, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety, efficacy, and repeat PK period (Part 3) and also includes a surgical sub-study for subjects enrolled in Parts 2 and 3.
Primary Outcome
The investigator rated the efficacy of the treatment based on a 4-point rating scale "excellent, good, moderate or poor/no response". Efficacy ratings of "excellent" or "good" were considered treatment success for this end point; the percentage of bleeding events with a rating of excellent or good and the 95% confidence interval are presented. The denominator includes all treated bleeding events. The 95% confidence interval is based on a model to account for within-subject correlation.
Conditions Studied
Interventions
- BIOLOGICAL rVIII-SingleChain
- BIOLOGICAL Octocog alfa
Study Locations (20)
Other
- Study Site - Nedlands
- Study Site - Perth
- Study Site - Graz
- Study Site - Vienna
- Study Site - New Brunswick
- Study Site - Hradec Králové
- Study Site - Berlin
- Study Site - Berlin
- Study Site - Bonn
- Study Site - Giessen
- Study Site - Hamburg
California
- Study Site - Sacramento
- Study Site - San Diego
Colorado
- Study Site - Aurora
Connecticut
- Study Site - Hartford
Florida
- Study Site - Miami
Illinois
- Study Site - Chicago
Louisiana
- Study Site - New Orleans
Texas
- Study Site - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01486927 record still lists
NCT01486927 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (101% higher).
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 2 interventions - of which rVIII-SingleChain is the first listed.
NCT01486927 names 20 study sites across 9 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT01486927 about?
NCT01486927 is a clinical study titled "An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A". This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety, efficacy, and repeat PK period (Par...
What is the current status of trial NCT01486927?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2012-02. Estimated completion is 2014-12.
What conditions does trial NCT01486927 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT01486927?
The interventions under investigation include: rVIII-SingleChain (BIOLOGICAL), Octocog alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT01486927?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01486927 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia A
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01486927's enrollment target sits among peer trials
175 8th of 42 higher than 35 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A 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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