CompletedPhase 1/2

A Clinical Trial of Chidamide in the Management of Refractory ITP

China61 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant must be at least 18 years of age at the time of the screening. * Participant may be male or female. * Participant has a confirmed diagnosis of ITP according to the 2019 International Working Group assessment for more than 6 months at screening. * Participant who didn't respond or relapsed after previous first-line treatment, and lack of response to rituximab, TPO agents, or splenectomy. * Bone marrow biopsy is performed in participants over 60 years to exclude hematological malignancies. Exclusion Criteria: * Participant has evidence of a secondary cause of immune thrombocytopenia or to drug treatments or participant has a multiple immune cytopenia, e.g. Evan's syndrome. * Participant with the following conditions:severe dysfunction of the heart, kidney, liver, or lung; severe immunodeficiency; malignancy; HIV; hepatitis B or C virus infection; pregnancy or lactation.

What they're measuring

Overall response at week 12

Timeframe: week 12

Trial details

NCT IDNCT03838354

SponsorShandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01