Study of Immune Thrombocytopenia Pathogenesis:

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02042560

Acronym

PTI PARI

Enrollment

Registered

2014-01-23

Start date

2011-05-04

Completion date

2015-03-12

Last updated

2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Thrombocytopenia (ITP)

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.

Interventions

OTHERBlood samples

OTHERSpleen samples

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026