An Open-label, Randomized Multicenter Investigation of High-dose Dexamethasone Combining Thalidomide Versus High-dose Dexamethasone Mono-therapy for Management of Newly-diagnosed Immune Thrombocytopenia
Overview
- Phase
- Phase 2
- Intervention
- Dexamethasone
- Conditions
- Immune Thrombocytopenia
- Sponsor
- Shandong University
- Locations
- 1
- Primary Endpoint
- Evaluation of platelet response
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of thalidomide combining with high-dose dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone mono-therapy.
Detailed Description
The investigators are undertaking a multicenter, randomized controlled trial of 200 primary ITP adult patients from 5 medical centers in China. One part of the participants are randomly selected to receive Thalidomide (given at a dose of 150mg for 15 consecutive days), combining with dexamethasone (given intravenously at a dose of 40 mg per day for 4 days, the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). 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 thalidomide combining with high-dose dexamethasone therapy compared to high-dose dexamethasone for the treatment of adults with ITP.
Investigators
Ming Hou
Professor and Director
Shandong University
Eligibility Criteria
Inclusion Criteria
- ••newly diagnosed 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 hepatitis C virus, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome
Arms & Interventions
Thalidomide plus HD-Dexmamethasone
Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days
Intervention: Dexamethasone
Thalidomide plus HD-Dexmamethasone
Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days
Intervention: Thalidomide
Dexamethasone
Dexamethasone 40 mg per day, 4 consecutive days
Intervention: Dexamethasone
Outcomes
Primary Outcomes
Evaluation of platelet response
Time Frame: Newly diagnosed ITP in 3 months
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia