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NCT01992549 · ClinicalTrials.gov registry record · Phase 3
Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
A Phase 3 study of Severe Hemophilia A, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
- 15
- Study locations
NCT01992549: Completed Phase 3 study of Severe Hemophilia A, sponsored by Octapharma.
NCT01992549 is a Phase 3 study of Severe Hemophilia A that has completed, run by Octapharma. The registered enrollment target is 48 participants, below the 59-participant average among 4 other Severe Hemophilia A trials with a reported enrollment target (19% lower). The trial reports 15 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01992549, a Phase 3 study of Severe Hemophilia A, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of the study is to collect long-term data on 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 by the modified Bethesda assay (Nijmegen modification) using congenital FVIII-deficient human plasma spiked with Human-cl rhFVIII. The definition threshold for a "positive" inhibitor was if the modified Bethesda assay resulted in a titre ≥0.6 BU/mL at any time point during the observation period.
Conditions Studied
Interventions
- BIOLOGICAL Human-cl rhFVIII
Study Locations (15)
Other
- Hospital for Sick Children - Toronto
- Hopital de la Timone - Marseille
- Hôpital Kremlin Bicètre - Paris
- Institute of Hematology and Transfusiology - Tbilisi
- Sahyadri Speciality Hospital - Pune
- Christian Medical College - Vellore
- IMSP Mother and Child Institute - Chisinau
- University Medical School - Warsaw
- The National Children Specialized Hospital "OHMATDET" - Kiev
- Danylo Halytsky Lviv National Medical University - Lviv
- Great Ormond Street Hospital for Children - London
California
- UC Davis Medical Center - Sacramento
Alberta
- University of Alberta - Edmonton
British Columbia
- BC Children's Hospital - Vancouver
Ontario
- McMaster Children's Hospital - Hamilton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-04 |
| Est. Completion | 2018-12-27 |
| Phase | Phase 3 |
What the finished NCT01992549 record still lists
NCT01992549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 59-participant average among 4 other Severe Hemophilia A trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Severe Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which Human-cl rhFVIII is the first listed.
NCT01992549 lists 15 locations in 5 states (Other, California, Alberta).
Frequently Asked Questions
What is clinical trial NCT01992549 about?
NCT01992549 is a clinical study titled "Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII". The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.
What is the current status of trial NCT01992549?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2014-04. Estimated completion is 2018-12-27.
What conditions does trial NCT01992549 study?
This clinical trial studies the following conditions: Severe Hemophilia A.
What interventions are being tested in trial NCT01992549?
The interventions under investigation include: Human-cl rhFVIII (BIOLOGICAL).
Who is sponsoring clinical trial NCT01992549?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01992549 being conducted?
This trial has 15 study locations across California, Alberta, British Columbia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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