NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults

Immunologic Thrombcytopenic Purpura (ITP) Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172015
• Other study ID #: 2010-A00396-33
• Secondary ID: 2010 03
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: April 20, 2015
• Start date: September 2010
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Immunologic Thrombcytopenic Purpura (ITP) Adults
• Purpura
• Purpura, Thrombocytopenic

Intervention

Other:
• blood samples

Locations

Country	Name	City	State
France	APHM	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare NK cells functions, phenotypic changes and transcripts from ITP patients and controls in a case control, multicentric study	Flow cytometry,transcripts.	24 months	No
Secondary	Influence of the Ig (IV) treatment on ITP patients' NK cells		24 months	No