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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


Phase 3
N/A
N/A
Open (Enrolling by invite only)
Male
Hemophilia A

Thank you

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