Clinical trials: Coagulopathy
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, Hemophilia B
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
A study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior…
- Trial name
- NCT05568719
- Testing
- Testing of hepatic AAV Vector integration
- Where
- 39 sites in United States, Australia and 11 more
- Volunteers
- 173 people
- Sponsor
- Pfizer
Hemophilia A
Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A
This Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in Japanese patients with severe hemophilia A.
- Trial name
- GENEr8-JPN (NCT06224907)
- Testing
- Valoctocogene roxaparvovec
- Where
- 4 sites in Japan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- BioMarin Pharmaceutical
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis
Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia
Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.
- Conditions
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Trial name
- PAC326 (NCT02055781)
- Testing
- Pacritinib, Best Available Therapy
- Where
- 122 sites in United States, Australia and 10 more
- Volunteers
- 311 people
- Sponsor
- CTI BioPharma
Hemophilia A
Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery
The objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.
- Trial name
- NO PEACKS (NCT00922597)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 7 sites in Austria, Germany and 5 more
- Volunteers
- 26 people
- Sponsor
- Bayer
Congenital Bleeding Disorder, Haemophilia A
Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B
- Trial name
- NCT02084810
- Testing
- activated recombinant human factor VII, eptacog alfa (activated)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Fibrinogen Deficiency
Human Fibrinogen - Pharmacokinetics
This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen deficiency.
- Trial name
- NCT00496262
- Testing
- Human Fibrinogen Concentrate
- Where
- 15 sites in United States, Italy
- Volunteers
- 15 people
- Sponsor
- CSL Behring
Healthy Subjects, Purpura, Thrombocytopenic, Idiopathic
Eltrombopag Taste Testing in Healthy Adult Volunteers
Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric thrombocytopenia, this study will help determine the best tasting pediatric formulation of eltrombopag.
- Trial name
- NCT00487968
- Testing
- eltrombopag
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Immune Thrombocytopenia
A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia
Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot.
- Trial name
- NCT04278924
- Testing
- TAK-079
- Where
- 55 sites in United States, Bulgaria and 9 more
- Volunteers
- 41 people
- Sponsor
- Takeda
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, Glanzmann's Disease
A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding…
- Trial name
- NCT01876745
- Testing
- eptacog alfa (activated)
- Where
- Japan
- Volunteers
- 4 people
- Sponsor
- Novo Nordisk A/S
Hemophilia B, Blood Coagulation Disorders, Inherited
AAV Gene Therapy Screening/Observational Protocol (ECLIPSE)
Freeline is developing adeno-associated virus (AAV) vector based gene therapies for a number of diseases and is actively advancing a programme in Haemophilia B (HB).
- Conditions
- Hemophilia B, Blood Coagulation Disorders, Inherited, Blood Coagulation Disorder, Haematologic Disease
- Trial name
- ECLIPSE (NCT04272554)
- Where
- 56 sites in United States, Australia and 10 more
- Volunteers
- 37 people
- Sponsor
- Spur Therapeutics
Hemophilia A
Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A patients undergoing surgery.
- Trial name
- NCT00157105
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free
- Where
- 10 sites in United States
- Volunteers
- 59 people
- Sponsor
- Baxalta now part of Shire
Severe Sepsis, Coagulopathy
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
- Trial name
- NCT01598831
- Testing
- ART-123
- Where
- 161 sites in United States, Argentina and 22 more
- Volunteers
- 816 people
- Sponsor
- Asahi Kasei Pharma America Corporation
Hemophilia A
Study of a pd vWF/FVIII, Biostate®, in Subjects With Haemophilia A
The aim of this study are to assess the efficacy of Biostate® [Study Product (SP)] in subjects with Haemophilia A compare the pharmacokinetics of Biostate® [SP] with the previously marketed product Biostate® (here referred to as…
- Trial name
- NCT00879541
- Testing
- Biostate® [SP], Biostate® [RP]
- Where
- 14 sites in Bulgaria, North Macedonia and 2 more
- Volunteers
- 81 people
- Sponsor
- CSL Behring
Immune Thrombocytopenia
Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
This is an open-label, multi-center, single group, Phase 3 study for treatment with rilzabrutinib. The purpose of this study is to provide continuation of rilzabrutinib treatment to adult participants with ITP who have completed…
- Trial name
- NCT07216079
- Testing
- rilzabrutinib
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- Sanofi
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 B
Dose Confirmation Trial of AAV5-hFIXco-Padua
This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a treatment + post-treatment follow-up phase, and a long-term follow-up phase.
- Trial name
- NCT03489291
- Testing
- AAV5-hFIXco-Padua (AMT-061)
- Where
- 4 sites in United States
- Volunteers
- 3 people
- Sponsor
- CSL Behring
Essential Thrombocythemia (ET)
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.
- Trial name
- NCT01467661
- Testing
- SPD422 (anagrelide hydrochloride)
- Where
- 16 sites in Japan
- Volunteers
- 41 people
- Sponsor
- Shire
Haemophilia A
A Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge
Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A. The study aims to show similar levels of Mim8 in blood when using a new pen injector, called DV3407-C1 pen injector, and when using a syringe…
- Trial name
- NCT05681845
- Testing
- NNC0365-3769 (Mim8)
- Where
- Germany
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S