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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Single-arm Clinical Trial of the Low Dose Chidamide in the Management of Refractory Immune Thrombocytopenia

Conditions
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Thrombocytopenia

Intervention / Treatment
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* Drug: Chidamide
* Drug: Chidamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Chidamide 2.5 mg po tiw | Drug: Chidamide<br>* Chidamide 2.5 mg po biw, every four weeks for one cycle. It will be given three cycles.<br>* Other names: HBI-8000;|
| Experimental: B<br>Chidamide 5 mg po tiw | Drug: Chidamide<br>* Chidamide 5 mg po biw, every four weeks for one cycle. It will be given three cycles.<br>* Other names: HBI-8000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count | Platelet count will be observed at the third month after the first dose of Chidamide | the third month after the first dose of Chidamide | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy associated adverse events | The number and frequency of therapy associated adverse events | up to 1 year per subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ITP, Chidamide