Clinical trials: Coagulation Abnormalities
Hemophilia A
BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A
A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe…
- Trial name
- NCT00623727
- Testing
- rFVIII-FS/pegylated liposomes (BAY79-4980), rFVIII-FS/WFI (BAY14-2222)
- Where
- 95 sites in United States, Argentina and 24 more
- Volunteers
- 143 people
- Sponsor
- Bayer
Hemophilia A
BAX 855 Pediatric Study
The study purpose is: To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last.
- Trial name
- NCT02210091
- Testing
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, PEGylated Recombinant Factor VIII
- Where
- 39 sites in United States, Bulgaria and 9 more
- Volunteers
- 75 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A
A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A
Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels.
- Trial name
- PROTECT-VIII (NCT01580293)
- Testing
- BAY94-9027
- Where
- 59 sites in United States, Austria and 18 more
- Volunteers
- 145 people
- Sponsor
- Bayer
Hemophilia B
Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B
Primary Objective: To evaluate the safety (acute effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis and with respect to…
- Trial name
- NCT00768287
- Testing
- IB1001, nonacog alfa
- Where
- 23 sites in United States, France and 5 more
- Volunteers
- 77 people
- Sponsor
- Medexus Pharma, Inc.
Hemophilia A With Inhibitor
A Pharmacokinetic and Clotting Activity Study of FVIII-PEGLip
The purpose of this study is to demonstrate that PEGylated liposomes (PEGLip) can shield FVIII from the immune system and inhibitors, and therefore provide a prophylactic FVIII replacement therapy for patients with inhibitors to…
- Trial name
- NCT04592692
- Testing
- PEGylated Liposome (PEGLip)
- Where
- 5 sites in Russia
- Volunteers
- 20 people
- Sponsor
- Ascension Healthcare Development Limited
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
Hemophilia A or B
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
A study to evaluate the safety of Hympavzi under the actual use in patients with congenital hemophilia who do not have inhibitors.
- Trial name
- HIZ (NCT07161687)
- Testing
- Marstacimab
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Pfizer
Von Willebrand Disease (VWD), Von Willebrand Disease (VWD), Type 1
A Study Assessing HMB-002 in Participants With Von Willebrand Disease
This is a first-in-human (FIH), Phase 1/2, 3-part open-label, dose escalation, safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and efficacy study evaluating HMB-002 in participants with VWD.
- Conditions
- Von Willebrand Disease (VWD), Von Willebrand Disease (VWD), Type 1, Von Willebrand Disease (VWD), Type 2, Von Willebrand Disease (VWD), Type 3
- Trial name
- NCT06754852
- Testing
- HMB-002 (Part A), HMB-002 (Part B), HMB-002 with Concomitant Factor Concentrate (Part C) (Not Applicable in US)
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 108 people
- Sponsor
- Hemab ApS
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
Von Willebrand Diseases
Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment
The purpose of this study is to prospectively obtain reliable data on the bleeding and treatment pattern of patients with VWD undergoing on-demand treatment with a VWF-containing product over a period of 6 months.
- Trial name
- NCT04053699
- Testing
- Von Willebrand Factor-Containing Product
- Where
- 15 sites in United States, Belarus and 6 more
- Volunteers
- 56 people
- Sponsor
- Octapharma
Hemophilia A
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level < 1%).
- Trial name
- NCT00666406
- Testing
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM), Recombinant Factor VIII (rAHF)
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Baxalta now part of Shire
Severe Hemophilia A
A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A.
The purpose of the study is to learn about safety, how the body processes marstacimab and how it works in patients with severe hemophilia A without inhibitors.
- Trial name
- NCT06703606
- Testing
- MARSTACIMAB
- Where
- 10 sites in United States, India and 1 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
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
Von Willebrand Disease (VWD)
A Study on the Outcomes of Recombinant Von Willebrand Factor on Demand Treatment and Prevention and Treatment of Bleeding During and After Surgery in Adults With Inherited Von Willebrand Disease in the United Kingdom (UK)
This study is a retrospective chart review study and will collect data on real world use of vonicog alfa (Recombinant Von Willebrand Factor [rVWF]). Von Willebrand disease (VWD) is the most common inherited bleeding disorder.
- Trial name
- NCT06433778
- Testing
- No Intervention
- Where
- 7 sites in United Kingdom
- Volunteers
- 34 people
- Sponsor
- Takeda
Hemophilia A
Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase [IU/dL] per IU/kg infused) and major single-infusion pharmacokinetic parameters.
- Trial name
- NCT00289536
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free
- Where
- 8 sites in United States
- Volunteers
- 38 people
- Sponsor
- Baxalta now part of Shire
Hemophilia A
Study Evaluating Pharmacovigilance Of Refacto AF
The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
- Trial name
- NCT00895037
- Testing
- ReFacto AF (Moroctocog alfa)
- Where
- 24 sites in Austria, Germany
- Volunteers
- 101 people
- Sponsor
- Pfizer
Hemophilia A
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection
The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection (SWFI) and compare with those…
- Trial name
- NCT00952822
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII)
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Baxalta now part of Shire
Congenital Bleeding Disorder, Haemophilia A
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated…
- Trial name
- guardian™ 3 (NCT01138501)
- Testing
- turoctocog alfa
- Where
- 38 sites in United States, Brazil and 11 more
- Volunteers
- 65 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
A Study to Evaluate the Pharmacokinetics 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 at two dose levels in patients with hemophilia A.
- Trial name
- NCT03747653
- Testing
- ADVATE, FRSW107
- Where
- 5 sites in China
- Volunteers
- 12 people
- Sponsor
- Kaifeng Pharmaceutical (Group) Co., Ltd.
Hemophilia B
A Study to Evaluate the Safety and Efficacy of VGB-R04 in Adult Hemophilia B Patients
A multicenter, open, non-randomized, phase I/II, two-phase clinical study. The dose exploration phase was phase I, and the dose extension phase was phase II.
- Trial name
- NCT05441553
- Testing
- VGB-R04
- Where
- China
- Volunteers
- 26 people
- Sponsor
- Shanghai Vitalgen BioPharma Co., Ltd.