Back to resultsA Clinical Trial of the Low Dose Chidamide in the Management of Refractory ITP
Primary Purpose
Thrombocytopenia
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Thrombocytopenia focused on measuring ITP, Chidamide
Eligibility Criteria
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
Sites / Locations
- Qilu hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Chidamide 2.5 mg po tiw
Chidamide 5 mg po tiw
Outcomes
Primary Outcome Measures
Platelet count
Platelet count will be observed at the third month after the first dose of Chidamide
Secondary Outcome Measures
Therapy associated adverse events
The number and frequency of therapy associated adverse events
Full Information
NCT ID
NCT03838354
First Posted
November 27, 2018
Last Updated
February 11, 2019
Sponsor
Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT03838354
Brief Title
A Clinical Trial of the Low Dose Chidamide in the Management of Refractory ITP
Official Title
A Prospective, Single-arm Clinical Trial of the Low Dose Chidamide in the Management of Refractory Immune Thrombocytopenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
ITP, Chidamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Chidamide 2.5 mg po tiw
Arm Title
B
Arm Type
Experimental
Arm Description
Chidamide 5 mg po tiw
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
HBI-8000
Intervention Description
Chidamide 2.5 mg po biw, every four weeks for one cycle. It will be given three cycles.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
HBI-8000
Intervention Description
Chidamide 5 mg po biw, every four weeks for one cycle. It will be given three cycles.
Primary Outcome Measure Information:
Title
Platelet count
Description
Platelet count will be observed at the third month after the first dose of Chidamide
Time Frame
the third month after the first dose of Chidamide
Secondary Outcome Measure Information:
Title
Therapy associated adverse events
Description
The number and frequency of therapy associated adverse events
Time Frame
up to 1 year per subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Hou, doctor
Phone
0531-82169879
Email
houming@medmail.com.cn
Facility Information:
Facility Name
Qilu hospital, Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ming hou, doctor
Email
houming@medmail.com.cn
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of the Low Dose Chidamide in the Management of Refractory ITP
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