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NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01172015
First received: July 26, 2010
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Immunologic Thrombcytopenic Purpura (ITP) Adults
 Other: blood samples

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: NK-ITP STUDY : NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURPURA OF ADULTS.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Influence of the Ig (IV) treatment on ITP patients' NK cells [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTI patients
Study NK cells functions, phenotypic changes and transcripts from ITP patients
 Other: blood samples
healthy volunteers
Study NK cells functions, phenotypic changes and transcripts from healthy volunteers
 Other: blood samples

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172015

Contacts
Contact: NICOLAS Schleinitz +33491383482 nicolas.schleinitz@ap-hm.fr

Locations
France
APHM Recruiting
Marseille, France, 13
Contact: Schleinitz Nicolas     +33491383482     nicolas.schleinitz@ap-hm.fr    
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Schleinitz Nicolas APHM
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille, direction de la recherche
ClinicalTrials.gov Identifier: NCT01172015     History of Changes
Other Study ID Numbers: 2010-A00396-33, 2010 03
Study First Received: July 26, 2010
Last Updated: March 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
 Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013