Clinical trials: Hemophilia A
Congenital Bleeding Disorder, Haemophilia A
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the…
- Trial name
- NCT00837356
- Testing
- Advate®, turoctocog alfa
- Where
- 7 sites in Germany, Israel and 3 more
- Volunteers
- 23 people
- Sponsor
- Novo Nordisk A/S
Severe Hemophilia A
A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary…
- Trial name
- NCT05265286
- Testing
- FRSW117
- Where
- 5 sites in China
- Volunteers
- 15 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Hemophilia B
Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients
The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK) parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in previously treated patients (PTPs) with severe and…
- Trial name
- NCT01174446
- Testing
- BAX 326, BeneFIX
- Where
- 25 sites in Argentina, Brazil and 12 more
- Volunteers
- 86 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A
Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry
This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives.
- Trial name
- NCT03603275
- Testing
- New FVIII products
- Where
- 27 sites in United States
- Volunteers
- 3 people
- Sponsor
- Bayer
Healthy
Effects of LMWH in Healthy Subjects Treated With TB-402 and Effects of TB-402 in Healthy Subjects Treated With Warfarin
Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin
- Trial name
- NCT00618579
- Testing
- LWMH in TB-402 treated subjects or TB-402 in warfarin treated subjects
- Where
- Denmark
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- ThromboGenics
Healthy
A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers
The purpose of this study is to assess the use of 2 different Prothrombin Complex Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of rivaroxaban in healthy adult volunteers.
- Trial name
- NCT01656330
- Testing
- Rivaroxaban 20 mg twice daily, Rivaroxaban 20 mg once daily, Profilnine SD
- Where
- Belgium
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hemophilia A With Inhibitor, Hemophilia A With Anti Factor VIII
Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec in Hemophilia A With Active or Prior Inhibitors
This Phase I/II clinical study will evaluate the safety and efficacy of valoctocogene roxaparvovec in patients with severe haemophilia A and inhibitors to FVIII.
- Trial name
- GENEr8-INH (NCT04684940)
- Testing
- Valoctocogene roxaparvovec
- Where
- 9 sites in United States, Brazil and 5 more
- Volunteers
- 10 people
- Sponsor
- BioMarin Pharmaceutical
Congenital Bleeding Disorder, Haemophilia A
A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects
This trial is conducted in Europe. 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 NNC…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Healthy
- Trial name
- explorer™2 (NCT01631942)
- Testing
- NNC172-2021
- Where
- 6 sites in Austria, France and 3 more
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hemophilia A
A Long-Term Follow-Up Study in Severe Hemophilia A Subjects Who Received BMN 270 in a Prior BioMarin Clinical Trial (270-401)
The BMN 270 clinical development program consists of multiple interventional studies designed to assess the safety and efficacy of a single infusion of BMN 270 for at least 5 years post-infusion.
- Trial name
- GENEr8-LTE (NCT05768386)
- Where
- 41 sites in United States, Australia and 10 more
- Volunteers
- 172 people
- Sponsor
- BioMarin Pharmaceutical
Hemophilia B
Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use
This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation.
- Trial name
- NCT00167973
- Where
- 90 sites in Austria, Belgium and 8 more
- Volunteers
- 218 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hemophilia a, Hemophilia B
The Efficacy and Safety of SerpinPC in Participants with Severe Hemophilia a or Moderately Severe to Severe Hemophilia B
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of prophylactic SerpinPC administered subcutaneously (SC) to participants with severe hemophilia A (HemA) (with or without…
- Trial name
- PRESent-2 (NCT05789524)
- Testing
- SerpinPC
- Where
- 59 sites in United States, Armenia and 13 more
- Volunteers
- 60 people
- Sponsor
- ApcinteX Ltd
Hemophilia A, Hemophilia B
Global Epidemiologic Study of Preexisting Immunity to AAV in Adults With Severe Hemophilia
Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia B (coagulation factor IX [FIX] ≤2%).
- Trial name
- NCT03185897
- Testing
- Non-treatment, seroprevalence
- Where
- 23 sites in United States, Austria and 4 more
- Volunteers
- 242 people
- Sponsor
- Baxalta now part of Shire
Hemophilia B
LTFU for Gene Transfer Subjects With Hemophilia B
Several subjects enrolled in a multi-site, gene transfer clinical study to evaluate the intrahepatic administration of AAV2-hFIX16 vector for the treatment of severe hemophilia B between 2001 and 2009.
- Trial name
- NCT00515710
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Spark Therapeutics, Inc.
Hemophilia A
Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development
This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies.
- Trial name
- NCT01445197
- Testing
- Biostate
- Where
- 7 sites in Austria, Germany and 3 more
- Volunteers
- 1 people
- Sponsor
- CSL Behring
Acquired Hemophilia A
A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A
This study is a survey in Japan of Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA).
- Trial name
- NCT06461533
- Testing
- Susoctocog Alfa (Genetical Recombination)
- Where
- Japan
- Volunteers
- 25 people
- Sponsor
- Takeda
Hemophilia A
Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously…
- Trial name
- NCT02962765
- Where
- 39 sites in United States, Argentina and 11 more
- Volunteers
- 80 people
- Sponsor
- Octapharma
Hemophilia A
BAX 855 Dose-Escalation Safety Study
The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of…
- Trial name
- NCT01599819
- Testing
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, PEGylated Recombinant Factor VIII
- Where
- 8 sites in Bulgaria, Germany and 2 more
- Volunteers
- 19 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A
Goal Attainment and Physical Activity in People With Hemophilia A
This is a Phase 4, multi-center, observational study conducted in patients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa in the US and Japan.
- Trial name
- ACTIVIIITY (NCT06530030)
- Testing
- efanesoctocog alfa
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Sanofi
Haemophilia A, Haemophilia B
Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
The puropse of this non-interventional register and survey study is to identify the patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety for people with…
- Trial name
- MIND (NCT03276130)
- Where
- 5 sites in Denmark, Finland and 1 more
- Volunteers
- 2,300 people
- Sponsor
- Swedish Orphan Biovitrum
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