Status:
UNKNOWN
Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP
Lead Sponsor:
Shandong University
Collaborating Sponsors:
Second Affiliated Hospital of Medical College Shandong University
Shandong Provincial Hospital
Conditions:
Purpura, Thrombocytopenic, Idiopathic
Immune Thrombocytopenia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The project was undertaking by Qilu Hospital of Shandong University and other 18 well-known hospitals in China. In order to report the efficacy and safety of decitabine combining with dexamethasone fo...
Detailed Description
The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 200 ITP adult patients from 19 medical centers in China. One part of the participants are rand...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria for immune thrombocytopenia.
- within 3 months fromdiagnosis,untreated patients, may be male or female, between the ages of 18 \~ 80 years.
- To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
- Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
Exclusion
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- Patients who are deemed unsuitable for the study by the investigator.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03252457
Start Date
September 1 2018
End Date
December 1 2021
Last Update
August 15 2018
Active Locations (1)
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1
Qilu hospital, Shandong University
Jinan, Shandong, China, 250012