An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A
N/A
N/A
Male
Hemophilia A
Trial Information
An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A
Subject will follow either a prophylaxis or on-demand regimen, to be determined by the
investigator. The starting dose in this study will be determined by the clinical profile of
the patient in the preceding studies (A-LONG - 997HA301 and pediatric study 9HA02PED).
Inclusion Criteria:
- Subjects who have completed previous rFVIIIFc studies
- Ability to understand purposes and risks of the study and to provide signed and dated
informed consent
Exclusion Criteria:
- Confirmed positive high-titer inhibitor test
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Frequency of inhibitor development
Outcome Time Frame:
Up to 4 years
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
8HA01EXT
NCT ID:
NCT01454739
Start Date:
December 2011
Completion Date:
December 2015
Related Keywords:
- Hemophilia A
- rFVIIIFc
- A-LONG Extension
- Hemophilia A
- Hemorrhage
Name | Location |
|---|---|
| Michigan State University | East Lansing, Michigan 48824 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
| The University of Iowa | Iowa City, Iowa 52242 |
| University of Utah School of Medicine | Salt Lake City, Utah 84132 |
| University of California Davis Health System | Sacramento, California 95817 |
| Puget Sound Blood Center | Seattle, Washington 98014 |
| Indiana Hemophilia and Thrombosis Center | Indianapolis, Indiana 46260 |
| Hemophilia Center of Western PA | Pittsburgh, Pennsylvania 15213-4306 |
| Hemophilia Treatment Center | Los Angeles, California 90007 |
| Tulane University Hospital & Clinics | New Orleans, Louisiana 70112 |
| Hemophilia Treatment Center of Nevada | Las Vegas, Nevada 89109 |
| Jefferson University Physician | Philadelphia, Pennsylvania 19107 |
| Penn Hemophilia Program | Philadelphia, Pennsylvania 19104 |
| Gulf States Hemophilia and Thrombophilia Center | Houston, Texas 77030 |
