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NCT Number: NCT01172015

NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults

Immunologic thrombcytopenic purpura (ITP) affects both children and adults. The incidence is estimated in adults about 1,6/100 000/per year. Chronic and relapsing forms of the disease that represent 70% of adult cases are associated with impairment of quality of life related to treatments side effects and bleeding. ITP is secondary to the destruction of circulating platelets through an auto-immune process and to a decrease of platelet production in bone marrow. Auto antibodies are usually directed against epitopes of the GPIIb/IIIa, expressed by platelets. The destruction of the platelets seems to occur mainly in the spleen through antibody dependent cytotoxicity. Both macrophages and cytotoxic T lymphocytes subsets participate to the platelet destruction through the CD16, the low affinity receptor for the Fc of IgG. Thus the CD16 "pathway" is a target for treatments in ITP as for example intravenous immunoglobulins and more recently inhibitors of the syk kinase.

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Key information

Conditions

Immunologic Thrombcytopenic Purpura (ITP) Adults 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

Interventional

Phase

Not applicable

Primary location

APHM

Marseille, 13, France

About this study

Natural Killer cells (NK) cells, who are now implicated in the pathophysiology of several autoimmune diseases, express CD16 and display antibody dependent cytotoxicty. Moreover NK cells are present in human spleen. However their role in ITP has not been studied so far. NK could represent a new target for treatments in ITP. We propose thus to conduct a study to characterizes NK cells changes in patients with ITP.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ITP patients,platelets less than 50000 G/L

Exclusion criteria

  • Secondary ITP (VIH, VHC...)
  • treatment with Immunosuppressive agents except corticoids (10 mg/day)
  • treatment with Ig IV less than 3 weeks
  • treatment with Rifuximab less than 6 months

Treatment and study plan

Blood Samples

Other

Primary outcomes

  1. Compare NK cells functions, phenotypic changes and transcripts from ITP patients and controls in a case control, multicentric study

    Time frame: 24 months

    Flow cytometry,transcripts.

Secondary outcomes

  1. Influence of the Ig (IV) treatment on ITP patients' NK cells

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

NK-ITP STUDY : NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURPURA OF ADULTS.

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jul 29, 2010
Registry last updated
Apr 22, 2015

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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