Thrombocytopenia Clinical Trial
Official title:
A Prospective, Single-arm Clinical Trial of the Low Dose Chidamide in the Management of Refractory Immune Thrombocytopenia
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.
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. ;
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