High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
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
| Sponsors |
Lead Sponsor: Shandong University Collaborator:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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| Source | Shandong University | ||||
| 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. |
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| 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. |
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| Overall Status | Withdrawn | ||||
| Start Date | October 2013 | ||||
| Primary Completion Date | December 2014 | ||||
| Phase | Phase 2 | ||||
| Study Type | Interventional | ||||
| Primary Outcome |
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| Condition | |||||
| Intervention |
Intervention Type: Drug Intervention Name: Dexamethasone Description: Dexamethasone 40 mg per day, 4 consecutive days Intervention Type: Drug Intervention Name: Thalidomide Description: Thalidomide 150mg per day, 15 consecutive days Arm Group Label: Thalidomide plus HD-Dexmamethasone |
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| 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 Gender: All Minimum Age: 18 Years Maximum Age: 75 Years Healthy Volunteers: No |
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| Location |
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| Location Countries |
China |
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| Verification Date |
October 2013 |
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| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Shandong University Investigator Full Name: Ming Hou Investigator Title: Professor and Director |
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| Has Expanded Access | No | ||||
| Condition Browse | |||||
| Number Of Arms | 2 | ||||
| Arm Group |
Label: Thalidomide plus HD-Dexmamethasone Type: Experimental Description: Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days Label: Dexamethasone Type: Active Comparator Description: Dexamethasone 40 mg per day, 4 consecutive days |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: None (Open Label) |
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