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ClinicalTrials.gov public records Last synced Sep 27, 2026, 5:13 PM EDT

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Showing 1–7 of 7 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: BIIB031 (rFVIIIFc) Clear all
Completed Phase 3 Interventional Results available

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

NCT01454739
View directory record Official record
Conditions
Hemophilia A
Interventions
rFVIIIFc
Drug
Lead sponsor
Bioverativ Therapeutics Inc.
Industry
Eligibility
0 Years and older · Male only
Enrollment
240 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
22
States / cities
Los Angeles, California • Orange, California • Sacramento, California + 17 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 27, 2026, 5:13 PM EDT
Completed Phase 1 Interventional Results available

Pharmacokinetics of rFVIIIFc at Two Vial Strengths

NCT02083965
View directory record Official record
Conditions
Severe Hemophilia A
Interventions
rFVIIIFc
Biological
Lead sponsor
Bioverativ Therapeutics Inc.
Industry
Eligibility
12 Years and older · Male only
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
3
States / cities
Los Angeles, California • Salt Lake City, Utah • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 27, 2026, 5:13 PM EDT
Completed Phase 4 Interventional Results available

A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)

NCT03093480
View directory record Official record
Conditions
Hemophilia A With Inhibitors
Interventions
rFVIIIFc
Biological
Lead sponsor
Bioverativ, a Sanofi company
Industry
Eligibility
Male only
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
12
States / cities
Orange, California • Aurora, Colorado • Washington D.C., District of Columbia + 9 more
Source: ClinicalTrials.gov public record
Updated Mar 27, 2022 · Synced Sep 27, 2026, 5:13 PM EDT
Completed Phase 3 Interventional Results available

Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale

NCT02502149
View directory record Official record
Conditions
Severe Hemophilia A
Interventions
rFVIIIFc
Biological
Lead sponsor
Bioverativ Therapeutics Inc.
Industry
Eligibility
12 Years and older · Male only
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
8
States / cities
Los Angeles, California • Chicago, Illinois • Indianapolis, Indiana + 5 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 27, 2026, 5:13 PM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A

NCT01458106
View directory record Official record
Conditions
Hemophilia A
Interventions
BIIB031 (rFVIIIFc), FVIII (PK subgroup only)
Drug
Lead sponsor
Bioverativ Therapeutics Inc.
Industry
Eligibility
Up to 11 Years · Male only
Enrollment
71 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
12
States / cities
Los Angeles, California • Sacramento, California • San Diego, California + 9 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 27, 2026, 5:13 PM EDT
Completed Phase 3 Interventional Results available

An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

NCT02234323
View directory record Official record
Conditions
Hemophilia A
Interventions
rFVIIIFc
Biological
Lead sponsor
Bioverativ, a Sanofi company
Industry
Eligibility
Up to 5 Years · Male only
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
20
States / cities
Little Rock, Arkansas • Duarte, California • Sacramento, California + 16 more
Source: ClinicalTrials.gov public record
Updated Apr 10, 2022 · Synced Sep 27, 2026, 5:13 PM EDT
Terminated No phase listed Observational

Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes

NCT02392156
View directory record Official record
Conditions
Hemophilia A, Hemophilia B
Interventions
rFVIIIFc, rFIXFc, non-Fc FVIII replacement products, non-Fc FIX replacement products
Biological · Drug
Lead sponsor
Bioverativ Therapeutics Inc.
Industry
Eligibility
Male only
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015
U.S. locations
2
States / cities
Los Angeles, California • East Lansing, Michigan
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 27, 2026, 5:13 PM EDT