A Clinical Trial of the Low Dose Chidamide in the Management of Refractory ITP

Phase 2

• Conditions: Thrombocytopenia
• Interventions: Drug: Chidamide

• Registration Number: NCT03838354
• Lead Sponsor: Shandong University

Brief Summary

Nowdays HDACi's were more and more focused on the anti-inflammatory and immunomodulatory activities,independent of their known proapoptotic or cell cycle arrest actions on malignant cells. Low concentrations of HDACi's are effective in reducing inflammation and autoimmune response in humans with juvenile idiopathic arthritis and animal models of inflammatory bowel disease and arthritis. The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of the low dose chidamide in the management of refractory ITP.

Detailed Description

The investigators are undertaking a prospective, open, multicentre trial of 30 refractory ITP adult patients from 5 medical centers in China. 1/2 of the participants are randomly selected to receive Chidamide in 2.5 mg po tiw, every four weeks for one cycle and it will be given three cycles. The other part will receive Chidamide in 5 mg po tiw, every four weeks for one cycle and it will be given three cycles. The treatment was discontinued after 3 months without blood index reaction. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the low dose chidamide in the management of refractory ITP.

Study Timeline

• Study First Submitted: 2018-11-27
• Status Verified: 2019-01
• Study First Submitted QC: 2019-02-11
• Last Update Submitted: 2019-02-11
• Study First Posted: 2019-02-12
• Last Update Posted: 2019-02-12
• Study Start: 2019-06-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Refractory ITP patients need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion Criteria

• pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Chidamide	Chidamide 2.5 mg po tiw
B	Chidamide	Chidamide 5 mg po tiw

Primary Outcome Measures

Name	Time	Method
Platelet count	the third month after the first dose of Chidamide	Platelet count will be observed at the third month after the first dose of Chidamide

Secondary Outcome Measures

Name	Time	Method
Therapy associated adverse events	up to 1 year per subject	The number and frequency of therapy associated adverse events

Trial Locations

Locations (1)

Qilu hospital, Shandong University; 🇨🇳 Jinan, Shandong, China