Study of Immune Thrombocytopenia Pathogenesis:

Completed

• Conditions: Primary Immune Thrombocytopenia (ITP)

• Registration Number: NCT02042560
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-04
• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Primary Completion: 2015-03-12
• Study Completion: 2015-03-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood level T cell in ITP patients and in healthy controls	baseline
blood level T cell in ITP patients after treatments	change from baseline at 4 to 8 weeks

Secondary Outcome Measures

Name	Time	Method
blood level splenic T cell in ITP patients and in healthy controls	baseline
frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls	through study completion, an average of 3 years
level of T follicular helper cell	through study completion, an average of 3 years

Trial Locations

Locations (3)

CHU de Besançon; 🇫🇷 Besançon, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU de METZ; 🇫🇷 Metz, France