FindTrial
Sign In

rFVIIIFc

BIOLOGICAL8 trials

Sponsors

Bioverativ Therapeutics Inc., Bioverativ, a Sanofi company, Swedish Orphan Biovitrum

Conditions

Hemophilia AHemophilia A With InhibitorHemophilia A With InhibitorsHemophilia BSevere Hemophilia A

Phase 1

Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A
CompletedNCT01027377
Bioverativ Therapeutics Inc.Severe Hemophilia A
Start: 2009-12-31End: 2011-05-31Updated: 2020-12-19
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
CompletedNCT02083965
Bioverativ Therapeutics Inc.Severe Hemophilia A
Start: 2014-03-31End: 2015-05-31Updated: 2020-12-19

Phase 3

Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
CompletedNCT01454739
Bioverativ Therapeutics Inc.Hemophilia A
Start: 2011-12-31End: 2017-10-31Updated: 2020-12-19
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
CompletedNCT02234323
Bioverativ, a Sanofi companyHemophilia A
Start: 2015-01-12End: 2019-09-23Updated: 2022-04-11
Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale
CompletedNCT02502149
Bioverativ Therapeutics Inc.Severe Hemophilia A
Start: 2015-08-31End: 2017-06-30Updated: 2020-12-19

Phase 4

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)
CompletedNCT03093480
Bioverativ, a Sanofi companyHemophilia A With Inhibitors
Start: 2017-12-08End: 2021-02-16Updated: 2022-03-28

Unknown Phase

Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes
TerminatedNCT02392156
Bioverativ Therapeutics Inc.Hemophilia A, Hemophilia B
Start: 2015-07-31End: 2015-12-31Updated: 2020-12-19
rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
CompletedNCT03951103
Swedish Orphan BiovitrumHemophilia A With Inhibitor
Start: 2018-11-07End: 2022-09-30Updated: 2024-09-19

Related Papers

Immune Tolerance Induction With a Recombinant Factor VIII Fc in Haemophilia A: Data From a Chart Review Study.
2025-04-27
Rescue immune tolerance induction with a recombinant factor Fc-fused VIII: prospective ReITIrate study of clinical, humoral and cellular immune responses.
2024-11-23
Cost Comparison of Efanesoctocog Alfa with Existing Factor VIII Replacement Therapies for Major Surgeries in People with Severe Hemophilia a
Blood2024-11-05
Long-term efmoroctocog alfa prophylaxis improves perceived pain, mental, and physical health in patients with hemophilia A: <i>post hoc</i> analysis of phase III trials using patient-reported outcomes.
2024-07-30
A post hoc analysis of previously untreated patients with severe hemophilia A who developed inhibitors in the PUPs A-LONG trial
Blood Advances2024-01-241 citations
Recombinant factor VIII Fc fusion protein for first-time immune tolerance induction: final results of the verITI-8 study
Blood2023-02-0316 citations
First study of extended half-life rFVIIIFc in previously untreated patients with hemophilia A: PUPs A-LONG final results
Blood2022-04-1429 citations
Efficacy of rFVIIIFc for First-Time Immune Tolerance Induction (ITI) Therapy: Final Results from the Global, Prospective VerITI-8 Study
Blood2021-12-021 citations
Population Pharmacokinetic Analysis of Recombinant Factor VIII Fc Fusion Protein in Subjects With Severe Hemophilia A: Expanded to Include Pediatric Subjects
The Journal of Clinical Pharmacology2021-03-152 citations
Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study
Haemophilia2020-03-3072 citations
Design of a prospective observational study on the effectiveness and real-world usage of recombinant factor VIII Fc (rFVIIIFc) compared with conventional products in haemophilia A: the A-SURE study
BMJ Open2019-05-0110 citations
ASPIRE Final Results Confirm Established Safety and Sustained Efficacy for Up to 4 Years of Treatment With rFVIIIFc in Previously Treated Subjects With Severe Hemophilia A
Blood2018-11-295 citations
Long-Term Efficacy and Quality of Life with Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Prophylaxis in Pediatric, Adolescent, and Adult Subjects with Target Joints and Severe Hemophilia a
Blood2016-12-025 citations
Longitudinal Analysis of Long-Term Safety and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Children with Severe Hemophilia a
Blood2016-12-021 citations
Longitudinal Analysis of Long-Term Safety and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIFc) in Adults/Adolescents with Severe Hemophilia a
Blood2016-12-02
Long-Term Safety and Efficacy of rFVIIIFc in Adults and Adolescents with Severe Hemophilia A: A Longitudinal Analysis of A-LONG and ASPIRE
Blood2015-12-036 citations
Long-Term Efficacy of rFVIIIFc Prophylaxis in Pediatric, Adolescent, and Adult Subjects with Target Joints and Severe Hemophilia A
Blood2015-12-03
Long-term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A.
2015-07-2756 citations
Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients.
2012-01-05179 citations