NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults

NCT01172015 | Completed

• 2 other identifiers: 2010-A00396-332010 03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immunologic Thrombcytopenic Purpura (ITP) Adults

Outcome Measures

Primary Outcomes (1)

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

  Flow cytometry,transcripts.

  24 months

Secondary Outcomes (1)

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

  24 months

Study Arms (2)

PTI patients

EXPERIMENTAL

Study NK cells functions, phenotypic changes and transcripts from ITP patients

Other: blood samples

healthy volunteers

OTHER

Study NK cells functions, phenotypic changes and transcripts from healthy volunteers

Other: blood samples

Interventions

blood samples OTHER

PTI patients; healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ITP patients,platelets less than 50000 G/L

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

APHM

Marseille, 13, France

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Schleinitz Nicolas

  APHM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 29, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2014
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

FR (1)