Clinical trials: Factor VIII (FVIII)
Hemophilia A
A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A
Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels.
- Trial name
- PROTECT-VIII (NCT01580293)
- Testing
- BAY94-9027
- Where
- 59 sites in United States, Austria and 18 more
- Volunteers
- 145 people
- Sponsor
- Bayer
Chronic Hepatitis C Infection
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV)…
- Trial name
- NCT01260350
- Testing
- SOF, RBV, PEG
- Where
- 2 sites in New Zealand
- Volunteers
- 292 people
- Sponsor
- Gilead Sciences
Hemophilia A
BAX 826 Dose-Escalation Safety Study
1. To assess tolerability and safety of BAX 826 after a single infusion in previously treated patients (PTPs) with severe hemophilia A 2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE 3.
- Trial name
- NCT02716194
- Testing
- BAX 826, Octocog alfa
- Where
- 28 sites in Bulgaria, Germany and 7 more
- Volunteers
- 40 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A, Hemophilia B
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.
- Trial name
- NCT01757405
- Testing
- Recombinant Factor VIIa BI (rFVIIa BI)
- Where
- 16 sites in United States, Japan and 7 more
- Volunteers
- 40 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A With Inhibitors, Hemophilia B With Inhibitors
A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa
The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A…
- Trial name
- PERSEPT2 (NCT02448680)
- Testing
- Coagulation FVIIa (Recombinant)
- Where
- 9 sites in United States, Bulgaria and 4 more
- Volunteers
- 25 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Hemophilia A, Hemophilia B
Understanding Hemophilia A and B Drug Dosage Administration Patterns
Study Design A prospective observational, cross-sectional epidemiological study in U.S. site-based clinical practice settings. 30 sites will enroll approximately 300 patients Participating patients - or their caregiver in the…
- Trial name
- NCT03248141
- Testing
- Hemophilia B standard half-life, Hemophilia B extended half-life, Hemophilia A standard half-life
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Pfizer
Acquired Hemophilia A
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A
This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with acquired hemophilia A.
- Trial name
- NCT01178294
- Testing
- OBI-1
- Where
- 12 sites in United States, Canada and 2 more
- Volunteers
- 29 people
- Sponsor
- Baxalta now part of Shire
Hemophilia, Hemophilic Arthropathy
Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy
Severe hemophilia is characterized by frequent and lifelong bleeding, with more than 60% of bleeds occurring into joints . Repeated joint bleeding leads to chronic synovitis, cartilage damage and bony destruction.
- Trial name
- NCT02601170
- Testing
- Platelet-Rich Plasma Intra-Articular Injection, Hyaluronic Acid Viscosupplementation
- Volunteers
- 22 people
- Sponsor
- Tri-Service General Hospital (TSGH)
Hemophilia
Weight-based Dosing in Hemophilia A
Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which promotes blood clotting is missing or does not work properly. Individuals with hemophilia A are at risk for bleeding.
- Trial name
- NCT02586012
- Testing
- rFVIII
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Craig Seaman
Hemophilia A
Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants
This multicenter, open-label, Phase 3 study with randomized and non-randomized arms is designed to investigate the efficacy, safety, and pharmacokinetics of emicizumab in participants with hemophilia A regardless of factor VIII…
- Trial name
- HAVEN 5 (NCT03315455)
- Testing
- Emicizumab
- Where
- 13 sites in China, Hong Kong and 2 more
- Volunteers
- 85 people
- Sponsor
- Hoffmann-La Roche
Hemophilia A
Study Evaluating Pharmacovigilance Of Refacto AF
The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
- Trial name
- NCT00895037
- Testing
- ReFacto AF (Moroctocog alfa)
- Where
- 24 sites in Austria, Germany
- Volunteers
- 101 people
- Sponsor
- Pfizer
Severe Hemophilia A
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A.
- Trial name
- NCT02083965
- Testing
- rFVIIIFc
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 19 people
- Sponsor
- Bioverativ Therapeutics Inc.
Hemophilia A With Inhibitors
Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors
The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and…
- Trial name
- ProFEIBA (NCT00221195)
- Testing
- activated prothrombin complex concentrate (FEIBA)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Tulane University School of Medicine
Hemophilia A
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia.
- Trial name
- NCT00950170
- Testing
- Laboratory Tests
- Where
- 11 sites in France, Germany and 5 more
- Volunteers
- 23 people
- Sponsor
- Pfizer
Hemophilia A
A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A
The goal of this study is to gather more information on safety and efficacy of Kovaltry for the prevention and treatment of bleeds in Chinese children, adolescents/adults with severe hemophilia A.
- Trial name
- NCT04565236
- Testing
- Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 1, Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 2, Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 3
- Where
- 10 sites in China
- Volunteers
- 45 people
- Sponsor
- Bayer
Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B
Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous [SC] treatment regimen with MarzAA for bleeding prophylaxis in 12 adult subjects with…
- Trial name
- NCT03407651
- Testing
- Coagulation Factor VIIa variant
- Where
- 9 sites in Armenia, Georgia and 3 more
- Volunteers
- 11 people
- Sponsor
- Catalyst Biosciences
Hemophilia A
Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A
An open-label, single dose pharmacokinetic study of Xyntha (Moroctocog Alfa (AF-CC), Recombinant Factor VIII) in male Chinese subjects with hemophilia A
- Trial name
- NCT02461992
- Testing
- Intravenous infusions of Xyntha
- Where
- 2 sites in China
- Volunteers
- 13 people
- Sponsor
- Pfizer
Hemophilia A, Severe Hemophilia A
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs)…
- Trial name
- NCT02172950
- Testing
- rVIII-SingleChain
- Where
- 64 sites in United States, Australia and 23 more
- Volunteers
- 246 people
- Sponsor
- CSL Behring
Chronic Hepatitis C, Hemophilia
Viral Kinetics in HCV Clearance in Subjects With Hemophilia
This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir.
- Trial name
- HCV/Hemophil (NCT01704521)
- Testing
- PegInterferon, Ribavirin, Telaprevir
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Kenneth Sherman
Hemophilia
LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures
The purpose of this study, PerSept 3, is to evaluate LR769 for the prevention of excessive bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have inhibitors to Factor VIII or Factor IX , are aged…
- Trial name
- PerSept3 (NCT02548143)
- Testing
- Coagulation Factor VIIa (Recombinant)
- Where
- 9 sites in United States, Mexico and 4 more
- Volunteers
- 12 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies