Status:
COMPLETED
A Clinical Trial of Chidamide in the Management of Refractory ITP
Lead Sponsor:
Shandong University
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
In this prospective, open-label, multicenter, randomized clinical trial, refractory ITP adult patients will be enrolled from five medical centers in China. Eligible participants will be randomly assig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03838354
Start Date
June 1 2021
End Date
September 1 2023
Last Update
August 26 2025
Active Locations (1)
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1
Qilu hospital, Shandong University
Jinan, Shandong, China