Clinical trials: Coagulation Disorder
Blood Loss, Surgical
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
- Trial name
- NCT03931031
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- HemoSonics LLC
Hemophilia A
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia.
- Trial name
- NCT00950170
- Testing
- Laboratory Tests
- Where
- 11 sites in France, Germany and 5 more
- Volunteers
- 23 people
- Sponsor
- Pfizer
Blood Loss Massive, Post Partum Hemorrhage
QStat Cartridge in Obstetric Patients
This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.
- Trial name
- NCT06255496
- Testing
- Quantra Hemostasis Analyzer with the QStat Cartridge
- Where
- 6 sites in United States
- Volunteers
- 296 people
- Sponsor
- HemoSonics LLC
Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias (RUBY-4)
The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and…
- Conditions
- Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
- Trial name
- NCT05757570
- Testing
- Povetacicept
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 30 people
- Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex
Hemophilia A, Hemophilia B
Global Epidemiologic Study of Preexisting Immunity to AAV in Adults With Severe Hemophilia
Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia B (coagulation factor IX [FIX] ≤2%).
- Trial name
- NCT03185897
- Testing
- Non-treatment, seroprevalence
- Where
- 23 sites in United States, Austria and 4 more
- Volunteers
- 242 people
- Sponsor
- Baxalta now part of Shire
Disseminated Intravascular Coagulation (DIC)
A Clinical Study of KW-3357 in Patients With DIC
To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by the diagnostic…
- Trial name
- 3357-005 (NCT01384396)
- Testing
- KW-3357
- Where
- Japan
- Volunteers
- 15 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Acquired Thrombotic Thrombocytopenic Purpura
Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic…
- Trial name
- NCT02878603
- Testing
- Caplacizumab, Standard of Care
- Where
- 45 sites in United States, Austria and 11 more
- Volunteers
- 104 people
- Sponsor
- Sanofi
Hemophilia B
Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B
This is a phase 3, prospective, open-label, single-arm, single-dose, multicenter study investigating the efficacy, safety, and tolerability of CSL222 (AAV5-hFIXco-Padua) in adolescent male participants with severe or moderately…
- Trial name
- IX-TEND 3004 (NCT07080905)
- Testing
- CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua)
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 20 people
- Sponsor
- CSL Behring
Primary Immune Thrombocytopenia
A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia…
- Trial name
- myOpportunITy1 (NCT04200456)
- Testing
- Rozanolixizumab
- Where
- 29 sites in United States, Bulgaria and 14 more
- Volunteers
- 33 people
- Sponsor
- UCB Biopharma SRL
Essential Thrombocythemia
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant…
- Trial name
- NCT06079879
- Testing
- Bomedemstat, Anagrelide, Busulfan
- Where
- 161 sites in United States, Argentina and 22 more
- Volunteers
- 340 people
- Sponsor
- Merck Sharp & Dohme LLC
Focal Segmental Glomerulosclerosis, Minimal Change Disease
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.
- Conditions
- Focal Segmental Glomerulosclerosis, Minimal Change Disease, Immunoglobulin A Nephropathy, IgA Vasculitis
- Trial name
- EPPIK (NCT05003986)
- Testing
- Sparsentan
- Where
- 47 sites in United States, Germany and 6 more
- Volunteers
- 67 people
- Sponsor
- Travere Therapeutics, Inc.
Severe Hemophilia A
A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary…
- Trial name
- NCT05265286
- Testing
- FRSW117
- Where
- 5 sites in China
- Volunteers
- 15 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Hemophilia A
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
Primary Objective: To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A Secondary Objectives: To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
- Trial name
- XTEND-ed (NCT04644575)
- Testing
- efanesoctocog alfa (BIVV001)
- Where
- 85 sites in United States, Argentina and 21 more
- Volunteers
- 261 people
- Sponsor
- Bioverativ, a Sanofi company
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
Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
Sobi.BIVV001-003 is an open-label, 2-period, fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa pegol or turoctocog alfa pegol…
- Trial name
- NCT06579144
- Testing
- Efanesoctocog alfa
- Where
- 7 sites in Bulgaria, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- Swedish Orphan Biovitrum
Immune Thrombocytopenic Purpura (ITP)
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic…
- Trial name
- NCT03866577
- Testing
- Biological: M254, Intravenous immunoglobulin (IVIg)
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Momenta Pharmaceuticals, Inc.
Congenital Bleeding Disorder, Haemophilia A
Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A
The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.
- Trial name
- alleviate 1 (NCT02994407)
- Testing
- turoctocog alfa pegol
- Where
- 19 sites in United States, Austria and 4 more
- Volunteers
- 50 people
- Sponsor
- Novo Nordisk A/S
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- explorer™4 (NCT03196284)
- Testing
- Concizumab, Eptacog alfa
- Where
- 22 sites in United States, Austria and 12 more
- Volunteers
- 26 people
- Sponsor
- Novo Nordisk A/S
Von Willebrand Disease
Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age
The WIL-33 study aimed to determine the efficacy, pharmacokinetics, immunogenicity and safety of wilate as routine prophylaxis in up to 12 paediatric patients (eight evaluable) with severe von Willebrand Disease VWD (defined as…
- Trial name
- NCT04953884
- Testing
- Wilate
- Where
- 9 sites in United States, Czechia and 5 more
- Volunteers
- 12 people
- Sponsor
- Octapharma
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