Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A

Status:	Completed
Conditions:	Anemia, Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	Any
Updated:	11/24/2018
Start Date:	December 2011
End Date:	October 2017

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

The primary objective of the study is to evaluate the long-term safety of recombinant human
Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary
objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and
treatment of bleeding episodes in participants with hemophilia A.

Participant will follow either a prophylaxis or on-demand regimen. The starting dose in this
study will be determined by the clinical profile of the participant in the preceding studies
A-LONG - 997HA301 (NCT01181128), pediatric study 8HA02PED (NCT01458106), 997HA307
(NCT02083965) and 997HA309 (NCT02502149).

Key Inclusion Criteria:

- Subjects who have completed previous rFVIIIFc studies (NCT01181128, NCT02083965,
NCT01458106 and NCT02502149)

- Ability to understand purposes and risks of the study and to provide signed and dated
informed consent (or assent, as applicable).

Key Exclusion Criteria:

- Confirmed positive high-titer inhibitor (≥5.00 BU/mL).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

We found this trial at

sites

Clinical Trial Facility in New Orleans Louisiana

New Orleans, Louisiana

from

New Orleans, LA