Clinical trials: Coagulation, Blood
Healthy
Effect of BIBT 986 Followed by BIBT 986 Given as IV Infusion on Tissue Factor Triggered Coagulation in Healthy Male Volunteers
To compare with placebo the anticoagulant activity of three dosages of BIBT 986 on parameters of coagulation, platelet activation and inflammation in a model of tissue factor triggered activation of the coagulation system; to…
- Trial name
- NCT02259881
- Testing
- Low dose of BIBT 986 CL, per i.v. infusion, Medium dose of BIBT 986 CL, per i.v. infusion, High dose of BIBT 986 CL, per i.v. infusion
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hemophilia A
Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients
The purpose of this study is to evaluate whether IMMUNATE S/D is effective and safe in the treatment of hemophilia A patients. The study consists of 3 parts: Part 1 is a pharmacokinetic comparison of IMMUNATE S/D and its…
- Trial name
- NCT00162019
- Testing
- Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment)
- Where
- 5 sites in Bulgaria, Czechia and 2 more
- Volunteers
- 56 people
- Sponsor
- Baxalta now part of Shire
Congenital Thrombotic Thrombocytopenic Purpura
Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP]
The purpose of this study is to assess the psychometric properties of a recently developed congenital thrombotic thrombocytopenic purpura (cTTP)-specific patient-reported outcomes (PRO) instrument.
- Trial name
- NCT03519672
- Testing
- No intervention
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 41 people
- Sponsor
- Baxalta now part of Shire
Hemophilia
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
- Trial name
- NCT05027230
- Testing
- STSP-0601 for Injection
- Where
- China
- Volunteers
- 77 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Hemophilia B
Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients
This study is a phase 1, open-label, multi-center, dose-escalation study to investigate the safety, pharmacokinetics and pharmacodynamics of ISU304/CB2679d in previously treated hemophilia B patients.
- Trial name
- NCT03186677
- Testing
- ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg, BeneFIX
- Where
- 3 sites in South Korea
- Volunteers
- 11 people
- Sponsor
- ISU Abxis Co., Ltd.
Haemophilia A
A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men
This study will test how different doses of study medicine (Inno8) work in the healthy men. The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with…
- Trial name
- VOYAGER1 (NCT06649630)
- Testing
- NNC0442-0344 A
- Where
- 2 sites in Germany
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hemophilia B
Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B
This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients with severe or moderately severe hemophilia B and severe bleeding type.
- Trial name
- NCT02396342
- Testing
- AAV5-hFIX
- Where
- 7 sites in Denmark, Germany and 1 more
- Volunteers
- 10 people
- Sponsor
- CSL Behring
Immune Thrombocytopenia
This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)
The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of this study is to determine the rate of subjects with a response.
- Trial name
- NCT02859909
- Testing
- BT595
- Where
- 22 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 34 people
- Sponsor
- Biotest
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
Coagulation
Thromboelastography (TEG) Reference Range Study
As part of a system wide reagent verification plan Haemoscope Corporation will be running a study to verify the reference intervals of many of the reagents.
- Trial name
- NCT01357928
- Where
- United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Haemonetics Corporation
Hemophilia B
Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B
Nonacog alfa is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia B.
- Trial name
- NCT04286412
- Testing
- Nonacog alfa
- Where
- 5 sites in India
- Volunteers
- 25 people
- Sponsor
- Pfizer
Severe Hemophilia B
Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B
The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy…
- Trial name
- NCT01027364
- Testing
- Factor IX (rFIXFc), rFIX
- Where
- 51 sites in United States, Australia and 15 more
- Volunteers
- 123 people
- Sponsor
- Bioverativ Therapeutics Inc.
Healthy
A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements
The purpose of the study is to characterize the distribution and sources of variability in whole blood clotting time (WBCT) measurements in human blood collected from healthy volunteers by 5 different technicians.
- Trial name
- NCT02205827
- Testing
- Single-arm
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
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