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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01454739
First received: September 29, 2011
Last updated: September 12, 2013
Last verified: September 2012
  Purpose

An Open-Label, Multicenter, Long-Term Study of 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.


Condition Intervention Phase
Hemophilia A
Drug: rFVIIIFc
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Frequency of inhibitor development [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of annualised bleeding episodes per subject [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 194
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: On-Demand Drug: rFVIIIFc
IV administration
Experimental: B: Prophylaxis Drug: rFVIIIFc
IV administration

Detailed Description:

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).

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454739

  Show 60 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01454739     History of Changes
Other Study ID Numbers: 8HA01EXT
Study First Received: September 29, 2011
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
rFVIIIFc
A-LONG Extension

Additional relevant MeSH terms:
Hemophilia A
Hemorrhage
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014