Regulatory B Cells and Chronic Immune Thrombocytopenia

Purpura, Thrombocytopenic, Idiopathic Clinical Trial

— PTIREG  

Official title:

The Role of Regulatory B Cells in the Chronic Immune Thrombocytopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891109
• Other study ID #: PTIREG
• 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

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Regulatory B Cells
• Thrombocytopenia

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