Clinical trials: Factor VIII (FVIII)
Haemophilia A
Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally…
- Trial name
- Protect-NOW (NCT03695978)
- Where
- 59 sites in United States, Argentina and 16 more
- Volunteers
- 200 people
- Sponsor
- Octapharma
Hemophilia A or B
PF-06741086 Multiple Dose Study in Severe Hemophilia
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of PF-06741086 in subjects with severe hemophilia.
- Trial name
- NCT02974855
- Testing
- PF-06741086
- Where
- 10 sites in United States, Chile and 4 more
- Volunteers
- 27 people
- Sponsor
- Pfizer
Haemophilia A, Haemophilia A With Inhibitors
A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A.
- Trial name
- FRONTIER 5 (NCT05878938)
- Testing
- NNC0365-3769 (Mim8) PPX
- Where
- 36 sites in United States, Austria and 10 more
- Volunteers
- 61 people
- Sponsor
- Novo Nordisk A/S
Healthy
Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402
Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402
- Trial name
- NCT00612417
- Where
- Denmark
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- ThromboGenics
Severe Hemophilia A With Inhibitor
Thrombin Generation Assay (TGA) as Predictive Test for Haemostatic. Effectiveness of FVIII Concentrates in Haemophiliac A With Inhibitors
This is an observational, prospective, longitudinal, multicenter, cohort study designed with the scope to verify whether or not TGA may predict effectiveness of different FVIII concentrates class (devoid or rich of VWF) in…
- Trial name
- PredicTGA (NCT01505946)
- Testing
- TGA (Thrombin generation Assay)
- Where
- 15 sites in Italy
- Volunteers
- 25 people
- Sponsor
- Grifols Italia S.p.A
Hemophilia A, Hemophilia B
A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150
Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels.
- Trial name
- NCT01625390
- Testing
- BAY86-6150, eptacog alfa [activated]
- Where
- 61 sites in United States, Australia and 27 more
- Volunteers
- 10 people
- Sponsor
- Bayer
Congenital Bleeding Disorder, Haemophilia A
To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan
This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.
- Trial name
- NCT02207218
- Testing
- turoctocog alfa
- Where
- 2 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Novo Nordisk A/S
Hemophilia
Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients
The project is an observational, multi-central, prospective, non-interventional and open-label data collection study on secondary prophylaxis with recombinant FVIII products in adolescents and adults with severe hemophilia A…
- Trial name
- NCT01817868
- Testing
- Recombinant Factor VIII (Kogenate, BAY14-2222)
- Where
- Turkey (Türkiye)
- Volunteers
- 73 people
- Sponsor
- Bayer
Congenital Bleeding Disorder, Haemophilia A
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untreated children with haemophilia…
- Trial name
- guardian™4 (NCT01493778)
- Testing
- turoctocog alfa
- Where
- 69 sites in United States, Algeria and 16 more
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A Without Inhibitor, Hemophilia B Without Inhibitor
Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors
The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B without inhibitors and is safe to use.
- Trial name
- NCT06569108
- Testing
- KN057
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Suzhou Alphamab Co., Ltd.
Hemophilia a
Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia a Monitoring
This observational study consists of two parts. In part one, case scenario focus groups with hemophilia A patients and healthcare providers (HCPs) will be held.
- Trial name
- NCT06369740
- Testing
- Case scenarios - questionnaire, Case scenarios - Focus groups, Use scenarios - Usability test
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Enzyre B.V.
Hemophilia A
Study of Emicizumab Prophylaxis in Participants With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures
This Phase IV, multicenter study will evaluate whether participants with Hemophilia A (PwHA) with or without inhibitors receiving emicizumab prophylaxis can safely undergo minor surgical procedures without additional prophylactic…
- Trial name
- NCT03361137
- Testing
- Emicizumab
- Where
- 8 sites in United States
- Volunteers
- 14 people
- Sponsor
- Genentech, Inc.
Congenital Bleeding Disorder, Haemophilia A
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects
This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab…
- Trial name
- NCT02490787
- Testing
- Concizumab
- Where
- 34 sites in United States, Australia and 13 more
- Volunteers
- 24 people
- Sponsor
- Novo Nordisk A/S
Factor VIII Deficiency, Congenital, Factor 8 Deficiency, Congenital
Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe
This study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe in the setting of routine practice. The primary objective is to detect medically significant events (factor VIII inhibitor).
- Conditions
- Factor VIII Deficiency, Congenital, Factor 8 Deficiency, Congenital, Autosomal Hemophilia A, Classic Hemophilia
- Trial name
- NCT03034044
- Volunteers
- 106 people
- Sponsor
- Pfizer
Hemophilia A
ADVATE Post Authorization Safety Surveillance
The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.
- Trial name
- NCT00214734
- Testing
- rAHF-PFM
- Where
- 37 sites in United States
- Volunteers
- 108 people
- Sponsor
- Baxalta now part of Shire
Haemophilia A, Haemophilia B
Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo
The purpose of the study is to investigate the safety and effectiveness of Alhemo in participants under real-world clinical practice in Japan. Total duration of this study is about 6 years.
- Trial name
- NCT06831734
- Testing
- Concizumab
- Where
- 23 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Novo Nordisk A/S
Haemophilia A, Haemophilia B
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in…
- Trial name
- PREVENT (NCT03055611)
- Testing
- ELOCTA, ALPROLIX
- Where
- 22 sites in Germany
- Volunteers
- 201 people
- Sponsor
- Swedish Orphan Biovitrum
Hemophilia A
Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.
- Trial name
- NCT01810666
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 5 sites in China
- Volunteers
- 30 people
- Sponsor
- Bayer
Hemophilia A
A Study of Standard and Individualized Prophylactic Treatment With Advate in Men and Boys With Severe Hemophilia A
The main aim of this study is to learn about changes in the lowest blood levels of Factor VIII in men and boys when upgraded from standard prophylaxis with Advate to individualized prophylaxis with Advate.
- Trial name
- HAPKIDO (NCT04953000)
- Where
- 13 sites in Russia
- Volunteers
- 94 people
- Sponsor
- Takeda
Haemophilia A
Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10)
The study investigates how well the medicine called turoctocog alfa pegol (N8-GP) works in previously treated Chinese patients with severe haemophilia A. Participants will be treated with N8-GP.
- Trial name
- Pathfinder10 (NCT05082116)
- Testing
- turoctocog alfa pegol (N8-GP)
- Where
- 11 sites in China
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S