Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura.

NCT04070599 | Completed Phase 3 DMC

• 1 other identifier: CHUBX 2010/30
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine the hemato-immunological parameters predictive of the evolution of a Immune thrombocytopenic purpura (ITP) towards chronicity, and to identify possible differences between the child and the adult.

Conditions

Immune Thrombocytopenic Purpura; Autoimmune Thrombocytopenia; Thrombopenia

Outcome Measures

Primary Outcomes (1)

• Complete remission yes/no

  The status of Immune thrombocytopenic purpura in adult and pediatric patients will be determined at 12 months of initial diagnosis according to the Rodeghiero criteria: complete remission if the platelet count is\> 100 G / L. A non-complete remission patient at 12 months will be considered to have a chronic Immune thrombocytopenic purpura.

  At 12 months of initial diagnosis

Secondary Outcomes (2)

• Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid)

  At Day14

• Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid)

  At Day 28

Study Arms (1)

Single arm

EXPERIMENTAL

Study of lymphocyte subpopulations, cytokine assays, identification of autoantibodies, study of CD40 platelet ligand, thrombopoietin assay

Biological: Collection of biological samples

Interventions

Collection of biological samples BIOLOGICAL

A collection of biological samples will be carried out, with the remainders of the immunological samples taken on dry tube: the serum of the patients, taken at the initial diagnosis, will be kept frozen at -20 ° C.

Single arm

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Minor patients aged 2 to 18 recruited at the Children's Hospital, in the service of Prof. Y. PEREL, Dr. N. ALADJIDI, CEREVANCE,
• Adult patients (\> 18 years old) recruited at the Haut-Lévêque hospital, Pr JL PELLEGRIN, Pr JF VIALLARD, GECAI,
• Patient with acute Immune thrombocytopenic purpura, seen at initial diagnosis or within 8 days (defined as thrombocytopenia \<100 G / L, after an infectious cause, drug or related to autoimmune disease, hematological malignancy or deficit Immune have been eliminated, Rodeghiero criteria, 2009).
• Written consent given by the patient, if he is of age, or by the person (s) having parental authority
• Patient affiliated or beneficiary of a social security scheme

You may not qualify if:

• Patient who has received specific treatment from an Immune thrombocytopenic purpura
• Patient with secondary Immune thrombocytopenic purpura (hematological malignancy, autoimmune disease, immunodeficiency, pregnancy)
• Patient placed under the protection of justice

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Carine GRIEB, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: April 12, 2011
• Primary Completion: March 5, 2014
• Study Completion: March 5, 2014
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share