Clinical trials: Factor VIII Deficiency
Hemophilia A With Inhibitor, Hemophilia A Without Inhibitor
Pharmacokinetic-guided Dosing of Emicizumab
The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of…
- Conditions
- Hemophilia A With Inhibitor, Hemophilia A Without Inhibitor, Hemophilia A, Severe, Adolescent
- Trial name
- DosEmi (NCT06320626)
- Testing
- Emicizumab - PK-guided dose reduction, Emicizumab - Dosis continuation group, Emicizumab - Dose adjustment group
- Where
- 8 sites in Netherlands
- Volunteers
- 95 people
- Sponsor
- Kathelijn Fischer
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
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
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
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
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.
HIV Infections, Hemophilia A
The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia
To determine if platelet dysfunction and/or pharmacologic drug interaction occurs in patients taking both AZT and ibuprofen, which might account for enhanced bleeding tendency.
- Trial name
- NCT00002276
- Testing
- Ibuprofen, Zidovudine
- Where
- United States
- Sponsor
- University of Pittsburgh
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
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 With Inhibitor, Haemophilia A Without Inhibitor
ATHN 7: Hemophilia Natural History Study
This is a real-world study of the safety of the treatments used for people with hemophilia. The study will follow people with hemophilia A or B from across the country for about 4 years as they receive treatment.
- Conditions
- Hemophilia A With Inhibitor, Haemophilia A Without Inhibitor, Hemophilia B With Inhibitor, Haemophilia B Without Inhibitor
- Trial name
- ATHN 7 (NCT03619863)
- Where
- 29 sites in United States
- Volunteers
- 395 people
- Sponsor
- American Thrombosis and Hemostasis Network
Hemophilia A
Treatment of Hemophilia A Patients With FVIII Inhibitors
This is a non-interventional, multicenter, observational, international study in male persons with haemophilia A who have developed inhibitors to any replacement coagulation factor VIII (FVIII) product.
- Trial name
- MOTIVATE (NCT04023019)
- Testing
- Nuwiq, Octanate, Wilate
- Where
- 2 sites in United States, Germany
- Volunteers
- 120 people
- Sponsor
- Emory University
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
Congenital Bleeding Disorder, Haemophilia A
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese…
- Trial name
- NCT01238367
- Testing
- turoctocog alfa
- Where
- 6 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital 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 congenital hemophilia A.
- Trial name
- NCT01434511
- Testing
- OBI-1
- Where
- 3 sites in United States, South Africa and 1 more
- Volunteers
- 1 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A
A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
- Trial name
- NCT04158934
- Testing
- ADYNOVI/ADYNOVATE
- Where
- 36 sites in United States, Bulgaria and 11 more
- Volunteers
- 207 people
- Sponsor
- Baxalta now part of Shire
Haemophilia A
An Open Study to Investigate the Safety and Efficacy of Optivate® in Haemophilia A Patients Undergoing Surgery.
The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.
- Trial name
- NCT02250482
- Testing
- Optivate® (Human Coagulation Factor VIII)
- Where
- 8 sites in Poland, United Kingdom
- Sponsor
- Bio Products Laboratory
Mild Haemophilia A Without Inhibitor
DDAVP vs. Exercise in Patients With Mild Hemophilia A
Individuals with mild hemophilia A (MHA) bleed infrequently but can in the setting of trauma which often is when participating in sports/exercise.
- Trial name
- NCT03136003
- Testing
- DDAVP, Exercise
- Where
- 2 sites in Canada
- Volunteers
- 30 people
- Sponsor
- The Hospital for Sick Children
Hemophilia, Embolization
Embolization in Hereditary Coagulopathies
This is a longitudinal, prospective study, which will include 30 subjects with hereditary coagulopathies, with arthropathy, chronic synovitis resulting from hemarthrosis of the elbows, knees and/or ankles followed up at the…
- Conditions
- Hemophilia, Embolization, Hemarthrosis, Clotting Factor Deficiency
- Trial name
- EHCO (NCT05629130)
- Testing
- embolization with spherical microparticles embosphere
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- University of Sao Paulo General Hospital