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Showing 1–18 of 18 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: 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 2, 2026, 9:16 PM EDT
Completed Phase 1Phase 2 Interventional Results available

A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)

NCT03205163
View directory record Official record
Conditions
Hemophilia A
Interventions
Advate (Low Dose), Advate (High Dose), BIVV001 (Low Dose), BIVV001 (High Dose)
Biological
Lead sponsor
Bioverativ, a Sanofi company
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
7
States / cities
Los Angeles, California • Indianapolis, Indiana • Iowa City, Iowa + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 18, 2022 · Synced Sep 2, 2026, 9:16 PM EDT
Completed Phase 3 Interventional Results available

A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A

NCT04161495
View directory record Official record
Conditions
Factor VIII Deficiency
Interventions
efanesoctocog alfa (BIVV001)
Biological
Lead sponsor
Bioverativ, a Sanofi company
Industry
Eligibility
12 Years and older
Enrollment
159 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
8
States / cities
Los Angeles, California • San Diego, California • Gainesville, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Sep 16, 2025 · Synced Sep 2, 2026, 9:16 PM EDT
Completed Phase 1 Interventional

Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

NCT01027377
View directory record Official record
Conditions
Severe Hemophilia A
Interventions
rFVIIIFc
Drug
Lead sponsor
Bioverativ Therapeutics Inc.
Industry
Eligibility
12 Years and older · Male only
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
5
States / cities
Los Angeles, California • Sacramento, California • Waltham, Massachusetts + 2 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 2, 2026, 9:16 PM EDT
Active, not recruiting Phase 3 Interventional

Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A

NCT04644575
View directory record Official record
Conditions
Hemophilia A
Interventions
efanesoctocog alfa (BIVV001)
Drug
Lead sponsor
Bioverativ, a Sanofi company
Industry
Eligibility
Not listed
Enrollment
261 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
16
States / cities
Los Angeles, California • San Diego, California • Gainesville, Florida + 12 more
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 2, 2026, 9:16 PM EDT
Terminated Phase 3 Interventional Results available

The Hemophilia Inhibitor Prevention Trial

NCT04303559
View directory record Official record
Conditions
Hemophilia A Without Inhibitor
Interventions
Eloctate Injectable Product, Emicizumab Injection [Hemlibra]
Drug
Lead sponsor
Margaret Ragni
Other
Eligibility
4 Months to 4 Years · Male only
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
3
States / cities
Little Rock, Arkansas • Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 10, 2023 · Synced Sep 2, 2026, 9:16 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 2, 2026, 9:16 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 2, 2026, 9:16 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 2, 2026, 9:16 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 2, 2026, 9:16 PM EDT
Completed Phase 1 Interventional

To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)

NCT04770935
View directory record Official record
Conditions
Von Willebrand's Disease (VWD)
Interventions
efanesoctocog alfa (BIVV001)
Drug
Lead sponsor
Bioverativ, a Sanofi company
Industry
Eligibility
18 Years to 65 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
2
States / cities
Iowa City, Iowa • Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 24, 2025 · Synced Sep 2, 2026, 9:16 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 2, 2026, 9:16 PM EDT
Terminated Phase 3 Interventional Results available

The Hemophilia Inhibitor Eradication Trial

NCT04303572
View directory record Official record
Conditions
Hemophilia A With Inhibitor
Interventions
Eloctate ITI, Emicizumab
Drug
Lead sponsor
Margaret Ragni
Other
Eligibility
Male only
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
2
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Feb 20, 2023 · Synced Sep 2, 2026, 9:16 PM EDT
Withdrawn Phase 3 Interventional

Hemophilia Inhibitor Clinical Trials (INHIBIT) Platform

NCT02196207
View directory record Official record
Conditions
Severe Hemophilia A
Interventions
Eloctate Prophylaxis, Emicizumab Prophylaxis, Eloctate ITI plus Emicizumab, Eloctate ITI
Drug
Lead sponsor
Margaret Ragni
Other
Eligibility
4 Months to 99 Years · Male only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Aug 19, 2019 · Synced Sep 2, 2026, 9:16 PM EDT
Completed Phase 3 Interventional Results available

Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A

NCT04759131
View directory record Official record
Conditions
Hemophilia A
Interventions
efanesoctocog alfa (BIVV001)
Drug
Lead sponsor
Bioverativ, a Sanofi company
Industry
Eligibility
Up to 11 Years · Male only
Enrollment
74 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
10
States / cities
Los Angeles, California • Gainesville, Florida • Atlanta, Georgia + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 10, 2025 · Synced Sep 2, 2026, 9:16 PM EDT
Completed Phase 4 Interventional Results available

Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI Therapies

NCT03103542
View directory record Official record
Conditions
Hemophilia A
Interventions
Recombinant coagulation factor (rFVIIIFc)
Biological
Lead sponsor
Swedish Orphan Biovitrum
Industry
Eligibility
Male only
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated Sep 18, 2024 · Synced Sep 2, 2026, 9:16 PM EDT
Completed Phase 3 Interventional Results available

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

NCT01181128
View directory record Official record
Conditions
Severe Hemophilia A
Interventions
Factor VIII (rFVIIIFc), Advate®
Drug
Lead sponsor
Bioverativ Therapeutics Inc.
Industry
Eligibility
12 Years and older · Male only
Enrollment
165 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
21
States / cities
Little Rock, Arkansas • Los Angeles, California • Orange, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jan 7, 2021 · Synced Sep 2, 2026, 9:16 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 2, 2026, 9:16 PM EDT