NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01172015
First received: July 26, 2010
Last updated: August 28, 2014
Last verified: August 2014

July 26, 2010
August 28, 2014
July 2010
July 2012   (final data collection date for primary outcome measure)
Compare NK cells functions, phenotypic changes and transcripts from ITP patients and controls in a case control, multicentric study [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Flow cytometry,transcripts.
Same as current
Complete list of historical versions of study NCT01172015 on ClinicalTrials.gov Archive Site
Influence of the Ig (IV) treatment on ITP patients' NK cells [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults
NK-ITP STUDY : 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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Immunologic Thrombcytopenic Purpura (ITP) Adults
Other: blood samples
  • Experimental: PTI patients
    Study NK cells functions, phenotypic changes and transcripts from ITP patients
    Intervention: Other: blood samples
  • healthy volunteers
    Study NK cells functions, phenotypic changes and transcripts from healthy volunteers
    Intervention: Other: blood samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
November 2014
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01172015
2010-A00396-33, 2010 03
No
Assistance Publique Hopitaux De Marseille, direction de la recherche
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Schleinitz Nicolas APHM
Assistance Publique Hopitaux De Marseille
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP