Clinical trials: Factor VIII (FVIII)
Haemophilia A
Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from…
- Trial name
- NCT04682145
- Testing
- Turoctocog alfa pegol
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Haemophilia A With Inhibitors
- Trial name
- HERO (NCT02241694)
- Testing
- No treatment given
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A With Inhibitors
A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)
The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.
- Trial name
- NCT03093480
- Testing
- rFVIIIFc
- Where
- 37 sites in United States, Belgium and 8 more
- Volunteers
- 16 people
- Sponsor
- Bioverativ, a Sanofi company
Haemophilia A
Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities
This is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions.
- Trial name
- THIRd (NCT04584892)
- Testing
- Turoctocog alfa
- Where
- 10 sites in Italy
- Volunteers
- 18 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle"
In this study researchers want to gather more information about safety and effectiveness of BAY 2599023 (DTX201), a drug therapy that delivers the human factor VIII gene into the human body by use of a viral vector to treat the…
- Trial name
- NCT03588299
- Testing
- BAY2599023 (DTX201)
- Where
- 13 sites in United States, Bulgaria and 4 more
- Volunteers
- 11 people
- Sponsor
- Bayer
Hemophilia A
Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII
The purpose of this research study is to determine the effectiveness, safety, and pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are younger than 6 years of age, with severe or moderately…
- Trial name
- NCT00543439
- Testing
- Moroctocog alfa (AF-CC)
- Where
- 28 sites in United States, Argentina and 11 more
- Volunteers
- 66 people
- Sponsor
- Pfizer
Hemophilia A
A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection
Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (FRSW107) Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and…
- Trial name
- NCT05251090
- Testing
- ADVATE, FRSW107
- Where
- 6 sites in China
- Volunteers
- 13 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
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
Hemophilia A
Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A
The primary objectives of the study are to further evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in adolescent and adult patients with hemophilia A.
- Trial name
- RH-107-III02 (NCT04845399)
- Testing
- Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
- Where
- 16 sites in China
- Volunteers
- 101 people
- Sponsor
- Zhengzhou Gensciences Inc
Hemophilia
A Feasibility Study to Collect Data in Patients With Haemophilia
The purpose of this study is to collect reference data in patients with haemophilia. The study will also collect and store blood samples for potential future exploratory research in the disease area.
- Trial name
- NCT00798499
- Testing
- Laboratory variables
- Where
- 2 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Hemophilia A
Prophylaxis Versus On-demand Therapy Through Economic Report
The project is a controlled observational, multicenter, prospective data collection on secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A (FVIII < 1%).
- Trial name
- POTTER (NCT01159587)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- Italy
- Volunteers
- 58 people
- Sponsor
- Bayer
Hemophilia A
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
Primary objective To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection Secondary objectives To characterize additional pharmacokinetic…
- Trial name
- NCT05042440
- Testing
- Efanesoctocog alfa, Octocog alfa, Rurioctocog alfa pegol
- Where
- Bulgaria
- Volunteers
- 13 people
- Sponsor
- Sanofi
Congenital Bleeding Disorder, Haemophilia A
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).
- Trial name
- guardian TM 7 (NCT02938585)
- Testing
- turoctocog alfa
- Where
- 11 sites in China
- Volunteers
- 68 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
Study to Evaluate the Efficacy and Safety of Valoctocogene Roxaparvovec, With Prophylactic Steroids in Hemophilia A
This Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in combination with prophylactic corticosteroids in patients with severe hemophilia A.
- Trial name
- GENEr8-3 (NCT04323098)
- Testing
- valoctocogene roxaparvovec
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 22 people
- Sponsor
- BioMarin Pharmaceutical
Haemophilia A, Haemophilia A With Inhibitors
A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A
This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes.
- Trial name
- FRONTIER4 (NCT05685238)
- Testing
- Mim8
- Where
- 141 sites in United States, Austria and 30 more
- Volunteers
- 451 people
- Sponsor
- Novo Nordisk A/S
Severe Hemophilia A, Moderate Hemophilia A
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and <70 years…
- Trial name
- Beyond ABR (NCT05181618)
- Testing
- Emicizumab
- Where
- 26 sites in United States, Brazil and 10 more
- Volunteers
- 136 people
- Sponsor
- Hoffmann-La Roche