Clinical trials: Disorders, Blood Coagulation
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
Chronic Thrombocytopenia, Immune Thrombocytopenia
Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)
Core Study: To demonstrate that the efficacy of avatrombopag (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia…
- Trial name
- NCT01438840
- Testing
- Avatrombopag, Standard of care
- Where
- 25 sites in Australia, Belgium and 9 more
- Volunteers
- 49 people
- Sponsor
- Eisai Inc.
Blood Coagulation Disorders, Hemophilia A
Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods).
- Trial name
- Leopold I (NCT01029340)
- Testing
- Recombinant Factor VIII (BAY81-8973), Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 60 sites in United States, Argentina and 20 more
- Volunteers
- 74 people
- Sponsor
- Bayer
Hemophilia A
Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A
The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.
- Trial name
- NCT02634723
- Testing
- Octocog alfa (recombinant human coagulation factor VIII)
- Where
- 6 sites in China
- Volunteers
- 21 people
- Sponsor
- Baxalta now part of Shire
Von Willebrand Disease
Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease
The aim of this study is to assess the pharmacokinetics (PK), efficacy, and safety of Biostate® in subjects with Von Willebrand Disease (VWD).
- Trial name
- NCT00941616
- Testing
- Biostate®
- Where
- 5 sites in Bulgaria, Poland and 2 more
- Volunteers
- 22 people
- Sponsor
- CSL Behring
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.
Primary Immune Thrombocytopenia
Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia
QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP).
- Trial name
- NCT05621330
- Testing
- QL0911
- Where
- China
- Volunteers
- 216 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hemophilia A
Study of Recombinant Porcine Factor VIII (FVIII) in Hemophilia and Inhibitors to FVIII
The ability of a new recombinant porcine coagulation factor VIII, B-domain deleted (called "OBI-1"), to control the non-life- or limb-threatening bleeding episodes patients with hemophilia A commonly develop is being evaluated.
- Trial name
- NCT00245245
- Testing
- recombinant porcine coagulation factor VIII (OBI-1)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Octagen Corporation
Immune Thrombocytopenia
Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)
Study in patients with persistent and chronic Immune Thrombocytopenia (ITP), who have failed to respond or relapsed after prior therapy, with a platelet count <30,000/µL.
- Trial name
- NCT04056195
- Testing
- SKI-O-703
- Where
- 27 sites in United States, Greece and 3 more
- Volunteers
- 61 people
- Sponsor
- Oscotec Inc.
Thrombocythemia, Essential, Primary Myelofibrosis
An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in participants with a Myeloproliferative Neoplasm (MPN) who participated in a prior…
- Trial name
- NCT05223920
- Testing
- Bomedemstat
- Where
- 19 sites in United States, Australia and 5 more
- Volunteers
- 81 people
- Sponsor
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Hemophilia A
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
- Trial name
- NCT05936580
- Testing
- Nuwiq
- Where
- 16 sites in United States, Finland and 8 more
- Volunteers
- 28 people
- Sponsor
- Octapharma
Obesity, Overweight
A Study Investigating the Effects of Neprinol Study Product on Vascular Function
This open-label study investigated the effectiveness of Neprinol on maintaining healthy cardiovascular health in overweight and obese adults. Subjects took 3 capsules, 3 times per day over a period of 12 weeks.
- Trial name
- NCT02862223
- Testing
- Neoprinol
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- KGK Science Inc.
Haemophilia B
A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN
This study will collect information on side effects and how well Refixia/REBINYN works during long-term treatment (prophylaxis) in males with haemophilia B.
- Trial name
- NCT03745924
- Testing
- Nonacog beta pegol
- Where
- 30 sites in Austria, Belgium and 11 more
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
Hemophilia B
Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B
The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and control of hemorrhaging during prophylaxis) of…
- Trial name
- NCT01271868
- Testing
- IB1001
- Where
- 10 sites in United States, India and 1 more
- Volunteers
- 9 people
- Sponsor
- Medexus Pharma, Inc.
Acquired Bleeding Disorder, Dengue Haemorrhagic Fever
Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever
This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).
- Trial name
- NCT01601613
- Testing
- activated recombinant human factor VII
- Where
- 9 sites in Malaysia, Philippines and 1 more
- Volunteers
- 28 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untreated children with haemophilia…
- Trial name
- guardian™4 (NCT01493778)
- Testing
- turoctocog alfa
- Where
- 69 sites in United States, Algeria and 16 more
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
Primary Immune Thrombocytopenia (ITP)
An Open-label Study of Intravenous Immunoglobulin (5%) for the Treatment of Primary Immune Thrombocytopenia
It is a clinical trial of a medicinal product Human Immunoglobulin for Intravenous Injection (5%) manufactured by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. (hereinafter referred to as 5% IVIG).
- Trial name
- NCT07233213
- Testing
- Human immunoglobulin (pH4) for intravenous injection
- Where
- 9 sites in Turkey (Türkiye)
- Volunteers
- 36 people
- Sponsor
- Grand Shuyang Life Sciences (Chengdu) Co., Ltd.
Haemophilia B
Post-marketing Surveillance (Use Result Surveillance) With Refixia®
The participants are invited to take part in this study because they have Haemophilia B. The purpose of this study is to assess the safety and effectiveness of Refixia® about long-term routine use in patients with Haemophilia B.
- Trial name
- NCT03875547
- Testing
- Refixia®
- Where
- 23 sites in Denmark, Japan
- Volunteers
- 28 people
- Sponsor
- Novo Nordisk A/S
Haemophilia A, Haemophilia B
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in…
- Trial name
- PREVENT (NCT03055611)
- Testing
- ELOCTA, ALPROLIX
- Where
- 22 sites in Germany
- Volunteers
- 201 people
- Sponsor
- Swedish Orphan Biovitrum
Acquired Bleeding Disorder, Bleeding During/Following Surgery
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem…
- Trial name
- NCT01564563
- Testing
- standard therapy, activated recombinant human factor VII
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Novo Nordisk A/S
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