Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes
NCT ID: NCT02392156
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3 participants
OBSERVATIONAL
2015-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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rFVIIIFc for hemophilia A
Administered based on the clinical judgment of the Prescribing Physician and according to the local approved drug label
rFVIIIFc
As described in the treatment arm
non-Fc (fusion protein) replacement products for hemophilia A
Administered based on the clinical judgment of the Prescribing Physician and according to the local approved drug label
rFVIIIFc
As described in the treatment arm
non-Fc FVIII replacement products
Standard plasma-derived (pd) or recombinant (r) FVIII concentrate and other traditional treatment options
rFIXFc for hemophilia B
Administered based on the clinical judgment of the Prescribing Physician and according to the local approved drug label
rFIXFc
As described in the treatment arm
non-Fc factor replacement products for hemophilia B
Administered based on the clinical judgment of the Prescribing Physician and according to the local approved drug label
rFIXFc
As described in the treatment arm
non-Fc FIX replacement products
Standard plasma-derived (pd) or recombinant (r) FIX concentrate and other traditional treatment options
Interventions
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rFVIIIFc
As described in the treatment arm
rFIXFc
As described in the treatment arm
non-Fc FVIII replacement products
Standard plasma-derived (pd) or recombinant (r) FVIII concentrate and other traditional treatment options
non-Fc FIX replacement products
Standard plasma-derived (pd) or recombinant (r) FIX concentrate and other traditional treatment options
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
MALE
No
Sponsors
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Swedish Orphan Biovitrum
INDUSTRY
Bioverativ Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Bioverativ Therapeutics Inc.
Locations
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Research Site
Los Angeles, California, United States
Research Site
East Lansing, Michigan, United States
Countries
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Other Identifiers
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997HA401
Identifier Type: -
Identifier Source: org_study_id