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NCT02821572 Clinical Trial

Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)

Immune Thrombocytopenia Clinical Trial

— PTI Fc  

Official title:
Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02821572
Other study ID # BONNOTTE PARI 2013
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2, 2014
Est. completion date September 2024

Study information
Verified date February 2024
Source Centre Hospitalier Universitaire Dijon
Contact Bernard BONNOTTE
Phone 3.80.29.34.32
Email bernard.bonnotte@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a peripheral destruction of platelets responsible for bleedings. Monocytes/macrophages play a double role by phagocyting platelets recognized by autoantibodies and by maintaining the autoimmune response via their antigen-presenting cell functions. Fcgamma receptors (FcγR), that are represented by activating receptors (FcγRI, FcγRIIa, FcγRIII) and an inhibiting one (FcγRIIb), are involved in the regulation of macrophages and have been reported to be dysregulated in autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematous. The aim of this study is to compare the expression of FcγR in patients with ITP on circulating monocytes and on splenic macrophages.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: ITP group - Patients who have provided written consent - Patients over 18 years - Patients with national health insurance - Patients with ITP, defined as thrombocytopenia < 100 G/L, after exclusion of infection- or drug-related thrombocytopenia and malignant hemopathy. Control Group - Persons who have provided a written consent - Persons over 18 years - Persons with national health insurance - Persons without autoimmune disease Exclusion Criteria: - Patients under guardianship - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• blood sample

Procedure:
• spleen sample

Locations
Country Name City State
France CHU Dijon Bourgogne Dijon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1. The expressions of the activating Fc?Rs and the inhibiting receptor (Fc?RIIb) on monocytes will be compared between ITP patients at diagnosis and controls - physiological parameter through study completion, an average of 2 years
Secondary 1. The expressions of the activating Fc?Rs and the inhibiting receptor (Fc?RIIb) on splenic macrophages will be compared between ITP patients and controls. - physiological parameter through study completion, an average of 2 years
See also
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Completed NCT02351622 - Caffeic Acid Tablets as a Second-line Therapy for ITP Phase 3
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Not yet recruiting NCT05562882 - A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia Early Phase 1