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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02891109
Other study ID # PTIREG
Secondary ID
Status Completed
Phase N/A
First received September 1, 2016
Last updated September 1, 2016
Start date January 2015
Est. completion date September 2015

Study information

Verified date August 2016
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority France: The Commission nationale de l’informatique et des libertés
Study type Observational

Clinical Trial Summary

The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown.


Description:

The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown. In our cohort of chronic immune thrombopenia and controls, we realized a flow cytometry analyze of B and T cells and a co-culture to determine regulatory B cells functionality.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Purpura, Thrombocytopenic, Idiopathic, chronic phase (>12 months)

- no treatment or thrombopoietin receptor agonists

Exclusion Criteria:

- < 18 years

- Purpura, Thrombocytopenic, Idiopathic, acute phase

- pregnancy

- others causes of thrombopenia

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
Biological tests
From the blood: B and T cells extraction then co-culture B and T cells and characterization of lymphocytes by flow cytometry

Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Regulatory B cells functionality inhibition of T cells proliferation with co-culture B and T cells 1 week No
Secondary Cytometry immunophenotyping of B and T cells characterization of B and T cells by flow cytometry 1 week No
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