Clinical trials: Disorders, Blood Coagulation
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 A
Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A
This study is a multi-center, open-label, single-arm trial to evaluate the efficacy,safety and pharmacokinetics of SCT800 in regular prophylaxis and perioperative treatment in patients (≥12 years old) with severe hemophilia A who…
- Trial name
- NCT03815318
- Testing
- Recombinant Human Coagulation FVIII
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Sinocelltech Ltd.
Haemophilia A, Haemophilia B
A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With Hemophilia
The Hemophilia Growth and Development Study (HGDS) nearly 25 years ago showed haemophilia and HIV impacted brain development, thinking, and behaviour in children and adolescents.
- Trial name
- eTHINK (NCT03660774)
- Testing
- No treatment given
- Where
- 22 sites in United States
- Volunteers
- 563 people
- Sponsor
- Novo Nordisk A/S
Hemophilia
Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor
This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.
- Trial name
- NCT05619926
- Testing
- STSP-0601 for Injection
- Where
- 12 sites in China
- Volunteers
- 32 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Hemophilia A
Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs
This is a multi-center, Phase 1/2/3, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H803 injection in severe Hemophilia A subjects.
- Trial name
- NCT06111638
- Testing
- Single dose intravenous injection of BBM-H803
- Where
- 10 sites in China
- Volunteers
- 55 people
- Sponsor
- Shanghai Xinzhi BioMed Co., Ltd.
Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment of acquired thrombotic thrombocytopenic purpura (aTTP)…
- Trial name
- SOAR-HI (NCT03922308)
- Testing
- SHP655, Standard of Care
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 28 people
- Sponsor
- Shire
Thrombotic Microangiopathies, ITP Immune-Mediated Thrombocytopenia
TGD001 Treatment in Thrombotic Microangiopathies
This is a Phase 1/2, prospective, adaptive design trial of TGD001 in participants with suspicion or clinical diagnosis of acute immune thrombotic thrombocytopenic purpura (iTTP) episodes and participants with suspicion or…
- Trial name
- NCT07459114
- Testing
- TGD001
- Volunteers
- 70 people
- Sponsor
- TargED Biopharmaceuticals B.V.
Von Willebrand Disease (vWD)
An Observational Study of Vonicog Alfa (rVWF) in Pediatric Participants With Von Willebrand Disease (vWD)
This study is conducted in Japan of vonicog alfa (rVWF) used to treat pediatric participants with Von Willebrand Disease (vWD). The main aim of the study is to evaluate adverse drug reaction and effectiveness of vonicog alfa…
- Trial name
- NCT07404644
- Testing
- vonicog alfa (rVWF)
- Where
- Japan
- Volunteers
- 13 people
- Sponsor
- Takeda
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
Blood Coagulation Disorder
Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants
Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).
- Trial name
- NCT06582563
- Testing
- Whole Blood Clotting Time
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Perosphere Technologies Inc.
Primary Immune Thrombocytopenia (ITP)
A Phase Ib/II Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)
A randomized, double-blind, placebo-controlled design was designed to evaluate the safety and tolerability, pharmacokinetic/pharmacodynamic profile, and immunogenicity of multiple administration of STSA-1301 subcutaneous…
- Trial name
- NCT06929299
- Testing
- STSA-1301 subcutaneous injection
- Where
- 7 sites in China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Jiangsu BioJeTay Biotechnology Co., Ltd.
Thrombotic Thrombocytopenic Purpura (TTP)
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Congenital thrombotic thrombocytopenic purpura (cTTP) is a rare blood disorder that some people are born with. It is caused by a problem in a gene passed down from parents to children, which affects the body's ability to produce…
- Trial name
- NCT07353099
- Testing
- No Intervention
- Where
- 7 sites in Austria, Germany
- Volunteers
- 50 people
- Sponsor
- Takeda
Factor VII Deficiency
Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII Deficiency
The purpose of this multicentre, randomized, double blinded, single dose, two-way cross-over study, is to compare the pharmacokinetics (PK) of biosimilar eptacog alfa (activated) with Novoseven in 24 patients, adult and children…
- Trial name
- NCT03079063
- Testing
- Eptacog alfa, biosimilar, Novoseven
- Where
- 2 sites in Iran
- Volunteers
- 24 people
- Sponsor
- AryoGen Pharmed Co.
Congenital Bleeding Disorder, Haemophilia A
A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A
- Trial name
- pathfinder™7 (NCT02920398)
- Testing
- turoctocog alfa pegol
- Where
- 14 sites in United States, Denmark and 4 more
- Volunteers
- 21 people
- Sponsor
- Novo Nordisk A/S
Severe Haemophilia A
Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A
To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients who received Human-cl rhFVIII as on demand…
- Trial name
- NCT01863758
- Testing
- Human-cl rhFVIII
- Where
- 20 sites in Austria, Bulgaria and 6 more
- Volunteers
- 66 people
- Sponsor
- Octapharma
Hemophilia B
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including: 1) Unknown…
- Trial name
- NCT00484185
- Testing
- BeneFIX (coagulation factor IX (recombinant))
- Where
- South Korea
- Volunteers
- 183 people
- Sponsor
- Pfizer
Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura
MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP
The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura (ITP).
- Trial name
- NCT01609452
- Testing
- Blisibimod
- Sponsor
- Anthera Pharmaceuticals
Haemophilia A
Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally…
- Trial name
- Protect-NOW (NCT03695978)
- Where
- 59 sites in United States, Argentina and 16 more
- Volunteers
- 200 people
- Sponsor
- Octapharma
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
A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B
This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose levels. The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia…
- Trial name
- rhFVIIa (NCT01708564)
- Testing
- rhFVIIa
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 15 people
- Sponsor
- rEVO Biologics
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