Clinical trials: Blood Coagulation Disorders
Hemophilia A
A Long-Term Follow-Up Study in Severe Hemophilia A Subjects Who Received BMN 270 in a Prior BioMarin Clinical Trial (270-401)
The BMN 270 clinical development program consists of multiple interventional studies designed to assess the safety and efficacy of a single infusion of BMN 270 for at least 5 years post-infusion.
- Trial name
- GENEr8-LTE (NCT05768386)
- Where
- 41 sites in United States, Australia and 10 more
- Volunteers
- 172 people
- Sponsor
- BioMarin Pharmaceutical
Sepsis, Blood Coagulation Disorders
Analysis of the Coagulopathy Developed by COVID-19 Infected Patients
Increased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death.
- Conditions
- Sepsis, Blood Coagulation Disorders, Thrombin, Disseminated Intravascular Coagulation
- Trial name
- COVID-TGT (NCT04356950)
- Testing
- Thrombin generation test assay, Fibrin generation markers assays
- Where
- 4 sites in France
- Volunteers
- 175 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Hemophilia A
Study to Evaluate the Efficacy and Safety of Valoctocogene Roxaparvovec, With Prophylactic Steroids in Hemophilia A
This Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in combination with prophylactic corticosteroids in patients with severe hemophilia A.
- Trial name
- GENEr8-3 (NCT04323098)
- Testing
- valoctocogene roxaparvovec
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 22 people
- Sponsor
- BioMarin Pharmaceutical
Hemophilia B
An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
Alprolix (rFIXFc) is a recombinant extended half-life coagulation factor product. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Alprolix in the on-demand and prophylactic…
- Trial name
- B-MORE (NCT03901755)
- Testing
- Alprolix
- Where
- 29 sites in Czechia, Greece and 7 more
- Volunteers
- 151 people
- Sponsor
- Swedish Orphan Biovitrum
Immune Thrombocytopenia, Blood Platelet Disorder
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.
- Conditions
- Immune Thrombocytopenia, Blood Platelet Disorder, Hematologic Diseases, Purpura, Thrombocytopenic
- Trial name
- NCT06291415
- Testing
- HMPL-523
- Where
- 28 sites in United States, Australia and 3 more
- Sponsor
- Hutchmed
Blood Coagulation Disorder, Postoperative Blood Loss
Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery
Tranexamic axid is routinely used as an antifibrinolytic agent in cardiac surgery to reduce the risk of blood loss and transfusion.
- Conditions
- Blood Coagulation Disorder, Postoperative Blood Loss, Adverse Drug Event, Fibrinolysis; Hemorrhage
- Trial name
- NCT07164300
- Testing
- Tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h, Tranexamic acid at a dose of 20 mg/kg, Tranexamic acid at a dose of 30 mg/kg
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- University of Ioannina
Transfusion Reaction, Transfusion Related Complication
Transfusion Surveillance in Anaesthesia
the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage.
- Conditions
- Transfusion Reaction, Transfusion Related Complication, Anesthesia, Anesthesia; Shock
- Trial name
- STAR (NCT06403163)
- Testing
- Transfusion
- Where
- Belgium
- Volunteers
- 50,000 people
- Sponsor
- Erasme University Hospital
Von Willebrand Diseases
Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other…
- Trial name
- NCT05776069
- Testing
- VGA039
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Vega Therapeutics, Inc
Hemophilia A, Gene Therapy
Gene Therapy Study in Severe Hemophilia A Patients With Antibodies Against AAV5
This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, single dose study to determine the safety of valoctocogene roxaparvovec (an Adenovirus-Associated Virus (AAV) based gene therapy vector) in severe…
- Conditions
- Hemophilia A, Gene Therapy, Clotting Disorders, Blood Disorder
- Trial name
- GENEr8-AAV5+ (NCT03520712)
- Testing
- Valoctocogene Roxaparvovec
- Where
- 9 sites in South Africa, South Korea and 2 more
- Volunteers
- 3 people
- Sponsor
- BioMarin Pharmaceutical
Ischemic Stroke
Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent
The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke…
- Trial name
- ELECTROSTROKE (NCT05004233)
- Testing
- Blood collection before antiplatelet treatment, Blood collection after antiplatelet treatment
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Bleeding Disorder
Early Genomic Testing for Inherited Bleeding Disorders
The investigators aim to test the introduction of genomic testing early in the diagnostic pathway for inherited bleeding disorders in patients who have not received a diagnosis after first-line testing.
- Trial name
- GT4BD (NCT06736158)
- Testing
- Genetic testing for inherited bleeding disorders
- Where
- 3 sites in Canada
- Volunteers
- 212 people
- Sponsor
- Queen's University
Thrombosis, Blood Coagulation Disorder
Dynamics of Platelet Activation in Patients With Ventricular Assist Device (VAD)
Consenting patients with end-stage heart failure that are implanted with/candidates for implant of a short-term/durable mechanical circulatory support device (e.g.: percutaneous microaxial pumps (Impella), extracorporeal membrane…
- Conditions
- Thrombosis, Blood Coagulation Disorder, Platelet Thrombus, Platelet Dysfunction Due to Aspirin
- Trial name
- PASVAD (NCT03255928)
- Testing
- PAS assay, TGT
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Scientific Institute San Raffaele
Severe Haemophilia A
Gene Therapy Study in Severe Haemophilia A Patients (270-201)
This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, dose escalation study in order to determine the safety and efficacy of valoctocogene roxaparvovec (an Adenovirus-Associated Virus based gene therapy…
- Trial name
- NCT02576795
- Testing
- valoctocogene roxaparvovec
- Where
- 5 sites in United Kingdom
- Volunteers
- 15 people
- Sponsor
- BioMarin Pharmaceutical
Hemophilia A
Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients (BMN 270-301)
This Phase III clinical study will assess the impact of BMN 270 (compared to FVIII prophylaxis) on the number of bleeding episodes irrespective of exogenous FVIII replacement treatment in the efficacy evaluation period (EEP)…
- Trial name
- BMN 270-301 (NCT03370913)
- Testing
- valoctocogene roxaparvovec
- Where
- 49 sites in United States, Australia and 11 more
- Volunteers
- 144 people
- Sponsor
- BioMarin Pharmaceutical
Blood Coagulation Disorder
The Fear F8ctor Study - Does Fear Induce a Blood Curdling State?
For centuries the term "blood curling" has been used to describe extreme frightening situations. However, the origin of this ancient theory has never been studied and it remains unknown if fear induces the coagulation system.The…
- Trial name
- FF8 (NCT02601053)
- Testing
- Dull movie, Scary (horrifying) movie, Heart rate measurement
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Hemophilia A, Hemophilia B
An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
The goal of this low-interventional study is to describe the overall joint health in patients with haemophilia A or haemophilia B prophylactically treated with rFVIIIFc or rFIXFc.
- Trial name
- JOIN-us (NCT05856266)
- Testing
- Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US), Haemophilia Joint Health Score (HJHS)
- Where
- 56 sites in Bulgaria, Croatia and 9 more
- Volunteers
- 10 people
- Sponsor
- Swedish Orphan Biovitrum
Blood Coagulation Disorders, Inherited, Thrombotic Disorder
Evaluation of Hemostasis in Bleeding and Thrombotic Disorders
The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.
- Trial name
- NCT00178594
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- The University of Texas Health Science Center, Houston
Hemophilia A
A Gene Transfer Study for Hemophilia A
This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.
- Trial name
- NCT03003533
- Testing
- SPK-8011
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 25 people
- Sponsor
- Spark Therapeutics, Inc.
Heart Diseases, Vascular Diseases
Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration…
- Conditions
- Heart Diseases, Vascular Diseases, Transfusion Related Complication, Coagulation Disorder, Blood
- Trial name
- NCT05806346
- Testing
- TXA administration
- Where
- 3 sites in South Korea
- Volunteers
- 764 people
- Sponsor
- Konkuk University Medical Center
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.