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Completed

NCT Number: NCT02042560

Study of Immune Thrombocytopenia Pathogenesis:

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.

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Key information

Conditions

Primary Immune Thrombocytopenia (ITP) Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Samples

Other

Spleen samples

Other

Primary outcomes

  1. blood level T cell in ITP patients and in healthy controls

    Time frame: baseline

  2. blood level T cell in ITP patients after treatments

    Time frame: change from baseline at 4 to 8 weeks

Secondary outcomes

  1. blood level splenic T cell in ITP patients and in healthy controls

    Time frame: baseline

  2. 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

  3. level of T follicular helper cell

    Time frame: through study completion, an average of 3 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: PTI PARI

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2014
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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