NCT02891109

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
Last Updated

September 7, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

September 1, 2016

Last Update Submit

September 1, 2016

Conditions

Purpura, Thrombocytopenic, IdiopathicRegulatory B Cells

Outcome Measures

Primary Outcomes (1)

  • Regulatory B cells functionality

    inhibition of T cells proliferation with co-culture B and T cells

    1 week

Secondary Outcomes (1)

  • Cytometry immunophenotyping of B and T cells

    1 week

Study Arms (2)

patients group

Adults patients with chronic immune thrombocytopenia

Biological: Biological tests

control group

Adults without immune thrombocytopenia

Biological: Biological tests

Interventions

Biological testsBIOLOGICAL

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

control grouppatients group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with a Purpura, Thrombocytopenic, Idiopathic, in chronic phase (\>12 months) and healthy volunteers as control residents in Brest town, France.

You may qualify if:

  • Purpura, Thrombocytopenic, Idiopathic, chronic phase (\>12 months)
  • no treatment or thrombopoietin receptor agonists

You may not qualify if:

  • \< 18 years
  • Purpura, Thrombocytopenic, Idiopathic, acute phase
  • pregnancy
  • others causes of thrombopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Christophe Jamin, PhD

    CHRU de Brest

    PRINCIPAL INVESTIGATOR

  • Lenaig Le Clech, MD

    CHRU Brest

    PRINCIPAL INVESTIGATOR

  • Brigitte Pan-Petesh, MD

    CHRU Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 7, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)