Clinical trials: Coagulation Protein Disorders
Hemophilia A
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate…
- Trial name
- NCT00141843
- Testing
- ReFacto AF, B-Domain deleted Recombinant Factor VIII, BDDrFVIII
- Where
- 41 sites in United States, Australia and 11 more
- Volunteers
- 100 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hemophilia B
Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy
This study will investigate the pharmacokinetics (PK), efficacy, and safety of rIX-FP for the routine prophylaxis of bleeding episodes in male Chinese previously treated patients (PTPs) with hemophilia B (FIX activity of ≤ 2%).
- Trial name
- NCT06399289
- Testing
- Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
- Where
- 7 sites in China
- Volunteers
- 23 people
- Sponsor
- CSL Behring
Haemophilia A
A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People
The purpose of this study is to test a new medicine called Inno8. The study will test how eating and drinking before and after taking Inno8 affects how well it is absorbed in the stomach. The study consists of four arms.
- Trial name
- NCT07238816
- Testing
- NNC0442-0344 A
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hemophilia A
An Open Label Study to Determine 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 evaluate the efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the Prevention and Treatment of Bleeding in patients with hemophilia A.
- Trial name
- NCT04456387
- Testing
- Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
- Where
- 17 sites in China
- Volunteers
- 119 people
- Sponsor
- Zhengzhou Gensciences Inc
Hemophilia B
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.
- Trial name
- NCT00866606
- Testing
- Benefix
- Where
- 6 sites in China
- Volunteers
- 35 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hemophilia A
Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after intravenous administration.
- Trial name
- NCT02483208
- Testing
- BAY81-8973, Advate
- Where
- Bulgaria
- Volunteers
- 18 people
- Sponsor
- Bayer
Haemophilia A, Haemophilia A With Inhibitors
A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors
This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors.
- Trial name
- NCT05053139
- Testing
- NNC0365-3769 (Mim8)
- Where
- 163 sites in United States, Austria and 32 more
- Volunteers
- 281 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A or B With Inhibitors
A Single-dose, Dose-escalation Study of a Long-acting MOD-5014 in Healthy Adult Male
A Phase 1, randomized, single-blind, placebo-controlled, single dose, dose-escalation study to assess the safety, pharmacokinetic and pharmacodynamic profile of subcutaneous administration of a long-acting recombinant factor VIIa…
- Trial name
- NCT02919800
- Testing
- MOD-5014
- Where
- Israel
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
Hemophilia A, Hemophilia B
Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B
Treatment with PF-06741086 is anticipated to demonstrate a clinically relevant advantage and/or a major contribution to patient care in comparison to current methods of treatment for hemophilia A or B because it works differently…
- Trial name
- NCT03938792
- Testing
- PF-06741086
- Where
- 62 sites in United States, Bulgaria and 18 more
- Volunteers
- 188 people
- Sponsor
- Pfizer
Blood Coagulation Disorders, Hemophilia A
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with…
- Trial name
- NCT00969319
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 2 sites in Mexico, Venezuela
- Volunteers
- 105 people
- Sponsor
- Bayer
Congenital Bleeding Disorder, Haemophilia A
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
- Trial name
- pathfinder™3 (NCT01489111)
- Testing
- turoctocog alfa pegol
- Where
- 70 sites in United States, Australia and 19 more
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Prospective, Non-interventional Study to Evaluate Immunogenicity of AryoSeven
This study evaluates the immunogenicity of the biosimilar rFVIIa (AryoSeven) in subjects receiving AryoSeven in real-life clinical practice.
- Conditions
- Hemophilia A With Inhibitor, Hemophilia B With Inhibitor, Factor VII Deficiency, Glanzmann's Thrombasthenia
- Trial name
- NCT03372993
- Where
- 2 sites in Iran
- Volunteers
- 200 people
- Sponsor
- AryoGen Pharmed Co.
Hemophilia A
Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A
The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate using two vials of 1500 IU potency dissolved…
- Trial name
- NCT00916032
- Testing
- Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
- Where
- 4 sites in Bulgaria, Russia
- Volunteers
- 29 people
- Sponsor
- Baxalta now part of Shire
Haemophilia A
A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A.
- Trial name
- VOYAGER2 (NCT07220564)
- Testing
- NNC0442-0344 A
- Where
- 33 sites in United States, Austria and 10 more
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hemophilia B
Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B
The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B.
- Trial name
- Kids B-LONG (NCT01440946)
- Testing
- rFIXFc, FIX
- Where
- 15 sites in United States, Australia and 4 more
- Volunteers
- 30 people
- Sponsor
- Bioverativ Therapeutics Inc.
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
Von Willebrand Disease (VWD)
A Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of SR604 Injection in Patients With Von Willebrand Disease
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in patients with von Willebrand disease.
- Trial name
- NCT07640893
- Testing
- SR604
- Where
- 9 sites in China
- Volunteers
- 24 people
- Sponsor
- Shanghai RAAS Blood Products Co., Ltd.
Haemophilia B
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol.
- Trial name
- NCT03690336
- Testing
- Nonacog beta pegol
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 10 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
Sobi.BIVV001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa pegol or turoctocog alfa pegol…
- Trial name
- NCT06579144
- Testing
- Efanesoctocog alfa
- Where
- 7 sites in Bulgaria, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- Swedish Orphan Biovitrum
Von Willebrand Disease, Blood Coagulation Disorders
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.
- Conditions
- Von Willebrand Disease, Blood Coagulation Disorders, Blood Platelet Disorders, Hematologic Disease
- Trial name
- NCT00168090
- Testing
- Blood coagulation Factor VIII and vWF, human
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- CSL Behring