Clinical Research Directory

Bleeding Disorder of Unknown Cause in the Netherlands

The purpose of the BDUC-iN study is to learn more about unexplained bleeding in individuals with bleeding disorder of unknown cause (BDUC). We aim to better understand why these individuals have increased bleeding and how it affects their health and daily life. The main questions of this study are: 1. What are the mechanisms underlying the bleeding tendency in BDUC? 2. How do bleeding symptoms affect patients' daily functioning and overall health-related quality of life? 3. How is care delivered to individuals with BDUC, and how can this be improved? Participants with increased bleeding tendency who remain undiagnosed after standard coagulation testing and are consequently classified as having BDUC will be enrolled across the haemophilia treatment centers in the Netherlands. They will undergo blood sampling for advanced hemostasis testing and genetic analysis. In addition, participants will complete validated questionnaires to assess bleeding symptoms and health-related quality of life. Participants will be followed longitudinally to evaluate how bleeding affects daily activities, medical procedures, and overall health-related quality of life.

Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage.

Primary purpose : Compare the sensitivity of several thromboplastin reagents of various origins to prothrombin time and factor II, V, VII and X assays in two different populations of patients : * Patients with an isolated extrinsic pathway deficiency (acquired or congenital) of factor II or V or VII or X. * Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment). Results of this work should improve knowledge of sensitivity of the screening test represented by the prothrombin time, depending on the origin of thromboplastin reagent used, in relation with coagulopathies mentioned above, as well as the performance of factors II, V, VII, X assays. This work would help to choice of the most suitable reagent for the needs of each hemostasis laboratory/center.

Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage

Primary purpose : Compare the sensitivity of several thromboplastin reagents of various origins to prothrombin time and factor II, V, VII and X assays in two different populations of patients : * Patients with an isolated extrinsic pathway deficiency (acquired or congenital) of factor II or V or VII or X. * Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment). Results of this work should improve knowledge of sensitivity of the screening test represented by the prothrombin time, depending on the origin of thromboplastin reagent used, in relation with coagulopathies mentioned above, as well as the performance of factors II, V, VII, X assays. This work would help to choice of the most suitable reagent for the needs of each hemostasis laboratory/center.

A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study

The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma. RIGEL Study