Clinical trials: Factor VIII (FVIII)
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
Hemophilia A, Hemophilia B
UK - EHL Outcomes Registry
Severe haemophilia A and B (SHA, SHB) are inherited bleeding disorders affecting male patients and are characterised by low levels of circulating clotting factors VIII and IX respectively.
- Trial name
- NCT02938156
- Where
- 21 sites in United Kingdom
- Volunteers
- 500 people
- Sponsor
- Royal Free Hospital NHS Foundation Trust
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 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
Hemophilia
Canadian CHO-KLAT/H-FIT Study - Quality of Life of, and Burden of Caring for, Persons With Hemophilia
The primary goal of this observational study is to determine if: health-related quality of life of boys with moderate/severe hemophilia A who are followed in Canadian pediatric hemophilia treatment centres is significantly…
- Trial name
- NCT06191068
- Where
- Canada
- Volunteers
- 190 people
- Sponsor
- The Hospital for Sick Children
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
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
Hemophilia
The World Federation of Hemophilia Gene Therapy Registry
The aim of the WFH GTR is to provide a database in which long-term data on PWH who receive gene therapy from around the world, will be collected and housed.
- Trial name
- WFH GTR (NCT04883710)
- Testing
- Gene therapy
- Volunteers
- 5,000 people
- Sponsor
- World Federation of Hemophilia
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
Internet-based Educational Program to Promote Self-Management for Teens With Hemophilia
In summary, there is a clear need to improve knowledge and self-management skills in adolescents with hemophilia. To date, there are no published accounts of self-management programs for this population.
- Trial name
- NCT01477437
- Testing
- Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention
- Where
- Canada
- Volunteers
- 29 people
- Sponsor
- The Hospital for Sick Children
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
Factor IX as Adjunctive Therapy to Emicizumab (EMIX)
This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive therapy to emicizumab)…
- Trial name
- NCT05281718
- Testing
- Factor IX
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Tulane University
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
What is the Feasibility of the ISTEP Exercise Test in Boys With Haemophilia
This study will be used to assess the feasibility and sensitivity of using the iSTEP, to assess exercise capacity in boys with haemophilia. The feasibility criteria to be explored includes: 1.
- Trial name
- NCT04076306
- Testing
- iSTEP exercise testing
- Where
- United Kingdom
- Volunteers
- 43 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Hemophilia
Risk Models to Optimise Prophylaxis Schedules in Children With Haemophilia
The MOrPH study is designed to identify optimal prophylaxis schedules for children with haemophilia. This involves development of combined pharmacokinetic and pharmacodynamic models.
- Trial name
- MOrPH (NCT02585635)
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Neuroscience Research Australia
Hemophilia A Without Inhibitor
HemFitBit, an Observational Study of Physical Activity in People With Moderate and Severe Haemophilia A
The study aims to describe physical activity (PA) levels in young people with haemophilia A in Norway compared with non-haemophilia controls, and to identify factors influencing PA.
- Trial name
- NCT04181697
- Testing
- PA measurement with Fitbit Charge 3, PA measurement with Fitbit and ActiGraph GT3X
- Where
- Norway
- Volunteers
- 40 people
- Sponsor
- Oslo University Hospital
Hemophilia A With Inhibitor
An Exploration of the Impact of Emicizumab on the Lives of People With Haemophilia and Inhibitors and Their Families
This study aims to examine the real-life experience and impact of using emicizumab in a cohort of patients with haemophilia and inhibitors, who were prescribed emicizumab as part of the early access to medicine schema…
- Trial name
- EmiandMe (NCT04723693)
- Testing
- Qualitative Interview
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Haemnet
Severe Hemophilia A Without Inhibitor
Clinical Outcomes of Low Dose PK-guided EHL FVIII Concentrates Versus Standard Prophylaxis in Severe Haemophilia A
Individualised pharmacokinetic (PK)-guided dosing of extended half-life (EHL) FVIII concentrates prophylaxis may reduce hemophilia A bleeding events than previous prophylactic regimen.
- Trial name
- NCT05281185
- Testing
- Extended half-life FVIII concentrates with PK-guided dosing, standard half-life FVIII concentrates with weight-based dosing
- Where
- Thailand
- Volunteers
- 15 people
- Sponsor
- Chulalongkorn University