ClinicalTrials.gov
ClinicalTrials.gov Menu

NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01172015
Recruitment Status : Completed
First Posted : July 29, 2010
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment Phase
Immunologic Thrombcytopenic Purpura (ITP) Adults Other: blood samples Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: NK-ITP STUDY : NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURPURA OF ADULTS.
Study Start Date : September 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Influence of the Ig (IV) treatment on ITP patients' NK cells [ Time Frame: 24 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172015


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

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01172015     History of Changes
Other Study ID Numbers: 2010-A00396-33
2010 03 ( Other Identifier: ap hm )
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

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