Brief Title
Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes
Official Title
A Global, Multicenter, Observational Study Evaluating the Impact of rFVIIIFc and rFIXFc on Patient-reported Treatment Burden and Health Economic Outcomes
Brief Summary
The primary objective of the study is to evaluate the effectiveness of prophylactic treatment with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion protein (rFIXFc) therapy as assessed by patient treatment burden and health economic outcomes while maintaining disease control in males with hemophilia A or B.
Study Type
Observational
Primary Outcome
Annualized number of injections for prophylactic treatment with a Factor VIII or Factor IX replacement product
Secondary Outcome
The total annualized factor consumption (in International Units [IU] per kilogram [IU/kg]) calculated for each participant
Condition
Hemophilia A
Intervention
rFVIIIFc
Study Arms / Comparison Groups
rFVIIIFc for hemophilia A
Description: Administered based on the clinical judgment of the Prescribing Physician and according to the local approved drug label
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
3
Start Date
July 2015
Completion Date
December 2015
Primary Completion Date
December 2015
Eligibility Criteria
Key Inclusion Criteria: - Have a medically documented diagnosis of hemophilia A or B that is being treated prophylactically with a factor replacement product not designed to have a prolonged half-life and satisfy a therapeutic indication for rFVIIIFc/rFIXFc per the approved local label - Have at least 50 prior exposure days (EDs) to any combination of factor replacement products - Have documented pre-study data available that confirm fulfillment of the eligibility criteria - Have no measurable inhibitor activity in a sample obtained within 4 weeks prior to the Baseline visit, and absence of clinical signs or symptoms of decreased response to the current factor replacement product Key Exclusion Criteria: - Have a diagnosis of any bleeding disorder other than hemophilia A or hemophilia B or an additional coagulation disorder(s) in addition to hemophilia A or hemophilia B - Have a prior history of anaphylaxis associated with any factor VIII (FVIII)/ factor IX (FIX) or intravenous immunoglobin administration - Had an inhibitor within 5 years before the Baseline visit. Note: A family history of inhibitors will not exclude the patient. - Past or current treatment with any factor replacement product with a prolonged half-life, including an Fc product, for the treatment of hemophilia NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02392156
Organization ID
997HA401
Responsible Party
Sponsor
Study Sponsor
Bioverativ Therapeutics Inc.
Collaborators
Swedish Orphan Biovitrum
Study Sponsor
Medical Director, Study Director, Bioverativ Therapeutics Inc.
Verification Date
August 2018