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: November 29, 2012

Last verified: November 2012

History of Changes

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:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Hemophilia

Drug Information available for: Kogenate Moroctocog Alfa Advate

U.S. FDA Resources

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

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:	November 29, 2012
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 May 16, 2013

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