- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02042560
Study of Immune Thrombocytopenia Pathogenesis: (PTI PARI)
Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.
The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Besançon, France, 25000
- CHU de Besancon
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Dijon, France, 21079
- CHU de Dijon
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Metz, France, 57000
- CHU de METZ
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with ITP, defined as thrombocytopenia < 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out
- persons who have provided written informed consent
Exclusion Criteria:
- persons without national health insurance
- persons under 18 years old
- patients under guardianship
- pregnancy
- subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Controls
|
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Patients with ITP
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood level T cell in ITP patients and in healthy controls
Time Frame: baseline
|
baseline
|
blood level T cell in ITP patients after treatments
Time Frame: change from baseline at 4 to 8 weeks
|
change from baseline at 4 to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood level splenic T cell in ITP patients and in healthy controls
Time Frame: baseline
|
baseline
|
frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
level of T follicular helper cell
Time Frame: through study completion, an average of 3 years
|
through study completion, an average of 3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
Other Study ID Numbers
- LORCERIE PARI 2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Immune Thrombocytopenia (ITP)
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Institute of Hematology & Blood Diseases Hospital...Henan Cancer Hospital; Beijing Children's Hospital; Tianjin Medical University... and other collaboratorsRecruitingPrimary Immune Thrombocytopenia (ITP)China
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argenxWithdrawnPrimary Immune Thrombocytopenia (ITP)
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Novartis PharmaceuticalsRecruitingPrimary Immune Thrombocytopenia (ITP)China, United States, Spain, Singapore, Austria, Germany, Belgium, Italy, Japan, Czechia, Hong Kong, Hungary, Malaysia, Argentina, Bulgaria, Turkey, Vietnam, Australia, Thailand, Mexico, United Kingdom, France, Romania, Norway, India
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