This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback


This study has been completed.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille Identifier:
First received: July 26, 2010
Last updated: April 20, 2015
Last verified: April 2015
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: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:

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 ]
    Flow cytometry,transcripts.

Secondary Outcome Measures:
  • Influence of the Ig (IV) treatment on ITP patients' NK cells [ Time Frame: 24 months ]

Enrollment: 80
Study Start Date: September 2010
Study Completion Date: June 2014
Primary Completion Date: June 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01172015

Marseille, France, 13
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Principal Investigator: Schleinitz Nicolas APHM
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT01172015     History of Changes
Other Study ID Numbers: 2010-A00396-33
2010 03 ( Other Identifier: ap hm )
Study First Received: July 26, 2010
Last Updated: April 20, 2015

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases processed this record on August 17, 2017