NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults
Primary Purpose
Immunologic Thrombcytopenic Purpura (ITP) Adults
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
About this trial
This is an interventional basic science trial for Immunologic Thrombcytopenic Purpura (ITP) Adults
Eligibility 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
Sites / Locations
- APHM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PTI patients
healthy volunteers
Arm Description
Study NK cells functions, phenotypic changes and transcripts from ITP patients
Study NK cells functions, phenotypic changes and transcripts from healthy volunteers
Outcomes
Primary Outcome Measures
Compare NK cells functions, phenotypic changes and transcripts from ITP patients and controls in a case control, multicentric study
Flow cytometry,transcripts.
Secondary Outcome Measures
Influence of the Ig (IV) treatment on ITP patients' NK cells
Full Information
NCT ID
NCT01172015
First Posted
July 26, 2010
Last Updated
April 20, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01172015
Brief Title
NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults
Official Title
NK-ITP STUDY : NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURPURA OF ADULTS.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunologic Thrombcytopenic Purpura (ITP) Adults
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTI patients
Arm Type
Experimental
Arm Description
Study NK cells functions, phenotypic changes and transcripts from ITP patients
Arm Title
healthy volunteers
Arm Type
Other
Arm Description
Study NK cells functions, phenotypic changes and transcripts from healthy volunteers
Intervention Type
Other
Intervention Name(s)
blood samples
Primary Outcome Measure Information:
Title
Compare NK cells functions, phenotypic changes and transcripts from ITP patients and controls in a case control, multicentric study
Description
Flow cytometry,transcripts.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Influence of the Ig (IV) treatment on ITP patients' NK cells
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Schleinitz Nicolas
Organizational Affiliation
APHM
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHM
City
Marseille
ZIP/Postal Code
13
Country
France
12. IPD Sharing Statement
Learn more about this trial
NATURAL KILLER CELLS IN IMMUNOLOGIC THROMBOCYTOPENIC PURpura of Adults
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