Immune Thrombocytopenia Clinical Trial
Official title:
A Multicenter Prospective Randomized Study of Dexamethasone Combined With Decitabine Versus Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
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 for the treatment of adults with immune thrombocytopenia (ITP), compared to dexamethasone alone .
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 1, 2021 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Meet the diagnostic criteria for immune thrombocytopenia. 2. within 3 months fromdiagnosis,untreated patients, may be male or female, between the ages of 18 ~ 80 years. 3. To show a platelet count < 30×10^9/L, and with bleeding manifestations. 4. Eastern Cooperative Oncology Group(ECOG)performance status = 2. Exclusion Criteria: 1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study. 3. Current HIV infection or hepatitis B virus or hepatitis C virus infections. 4. 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) 5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6. 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. 7. Patients who are deemed unsuitable for the study by the investigator. |
Country | Name | City | State |
---|---|---|---|
China | Qilu hospital, Shandong University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong University | Chinese Academy of Medical Sciences, Qingdao Central Hospital, Second Affiliated Hospital of Medical College Shandong University, Shandong Provincial Hospital |
China,
Din B, Wang X, Shi Y, Li Y. Long-term effect of high-dose dexamethasone with or without low-dose dexamethasone maintenance in untreated immune thrombocytopenia. Acta Haematol. 2015;133(1):124-8. doi: 10.1159/000362529. Epub 2014 Sep 20. — View Citation
Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kühne T, Ruggeri M, George JN. Standardization of terminology, d — View Citation
Wei Y, Ji XB, Wang YW, Wang JX, Yang EQ, Wang ZC, Sang YQ, Bi ZM, Ren CA, Zhou F, Liu GQ, Peng J, Hou M. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial. Blood. 2016 Jan 21;1 — View Citation
Zhou H, Hou Y, Liu X, Qiu J, Feng Q, Wang Y, Zhang X, Min Y, Shao L, Liu X, Li G, Li L, Yang L, Xu S, Ni H, Peng J, Hou M. Low-dose decitabine promotes megakaryocyte maturation and platelet production in healthy controls and immune thrombocytopenia. Throm — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of platelet response(continuous response rate) | Complete Response:a sustained (= 3 months) platelet count =100×10^9/L;response: a sustained (= 3 months) platelet count = 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart. | up to 1 year per subject | |
Secondary | therapy associated adverse events | The number and frequency of therapy associated adverse events | up to 1 year per subject |
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