Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP
NCT03252457 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2018-08-15
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 for the treatment of adults with immune thrombocytopenia (ITP), compared to dexamethasone alone .
Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Immune Thrombocytopenia
Interventions
- DRUG
-
Decitabine
given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3cycles
- DRUG
-
given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given.
Sponsors & Collaborators
-
Second Affiliated Hospital of Medical College Shandong University
collaborator OTHER -
Shandong Provincial Hospital
collaborator OTHER_GOV -
Qingdao Central Hospital
collaborator OTHER -
Chinese Academy of Medical Sciences
collaborator OTHER -
Shandong University
lead OTHER
Principal Investigators
-
Ming Hou, Dr · Shandong University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-01
- Primary Completion
- 2020-12-01
- Completion
- 2021-12-01
Countries
- China
Study Locations
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