Study of Immune Thrombocytopenia Pathogenesis:

Primary Immune Thrombocytopenia (ITP) Clinical Trial

— PTI PARI  

Official title:

Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042560
• Other study ID #: LORCERIE PARI 2010
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: March 13, 2018
• Start date: May 4, 2011
• Est. completion date: March 12, 2015

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 12, 2015
• Est. primary completion date: March 12, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Immune Thrombocytopenia (ITP)
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Other:
• Blood samples

• Spleen samples

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	CHU de Dijon	Dijon
France	CHU de METZ	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood level T cell in ITP patients and in healthy controls		baseline
Primary	blood level T cell in ITP patients after treatments		change from baseline at 4 to 8 weeks
Secondary	blood level splenic T cell in ITP patients and in healthy controls		baseline
Secondary	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
Secondary	level of T follicular helper cell		through study completion, an average of 3 years