Clinical trial

2012-03

Name
2012-03
Description
The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting both children and adults. HUS is characterized by the abnormal occurrence of diffuse thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting especially the kidneys and is associated with hemolytic anemia. One of the major problems encountered in the management of HUS is the absence of reliable marker of treatment response or relapse; conventional hematological markers being too insensitive to judge therapeutic efficacy or identify early relapse. Data from the literature suggest that the endothelial cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial activation plays a critical role in the initiation and / or relapse of the disease.The main objective of this study is to define a "vascular competence" profile in a population of patients with typical or atypical HUS; both in the acute phase and in remission of the disease.
Trial arms
Trial start
2013-02-11
Estimated PCD
2017-04-07
Trial end
2023-07-27
Status
Completed
Treatment
Extra blood draw samples
Arms:
patients with HUS
Size
19
Primary endpoint
number of circulating endothelial cells (CECs) and endothelial progenitor cells (EPCs)
36 months
number of endothelial progenitor cells (EPCs)
36 months
Eligibility criteria
Inclusion Criteria: * Patients with a clinical diagnosis of typical or atypical HUS in acute phase Exclusion Criteria: * Patient with positive serological screening test for infection with the HIV. * Patients with a history of cancer. * Patients who have undergone organ transplantation or bone marrow. * Patient with a vivid picture of autoimmune thrombotic thrombocytopenic purpura
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2023-07-28

1 organization

1 product

1 indication