drugset / Trial / NCT03838354

A Clinical Trial of Chidamide in the Management of Refractory ITP

NCT03838354

Phase 1/2 Completed 61 enrolled Shandong University
RandomizedCrossoverOpen-labelTreatment

Summary

Primary immune thrombocytopenia (ITP) is an autoimmune bleeding disorder. Increased macrophage phagocytosis of antibody-coated platelet as well as decreased number and/or impaired function of CD4+CD25+Foxp3+ regulatory T (Treg) cells have been shown to participate in the pathogenesis of ITP. Our preclinical data revealed that chidamide, a histone deacetylase inhibitor (HDACi), could attenuate macrophage phagocytosis of antibody-coated platelets, stimulate production of natural Foxp3+ Tregs, and upregulate CTLA4 expression through modulation of histone H3K27 acetylation. The project was undertaking by Qilu Hospital of Shandong University in China. In order to evaluate the efficacy and safety of chidamide at two different dosage regimens in adult patients with refractory ITP.

Timeline

Start
2021-06-01
Primary completion
2022-09-01
Completion
2023-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tucidinostat Small molecule 2.5 mg Oral
Subject Tucidinostat Small molecule 5 mg Oral

Indications