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High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP

Information source: Shandong University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Immune Thrombocytopenia

Intervention: Dexamethasone (Drug); Thalidomide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Shandong University

Overall contact:
Ming Hou, Doctor, Email: houming@medmail.com.cn

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evaluation of platelet response

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Ming Hou, Doctor, Email: houming@medmail.com.cn

Qilu hospital, Shandong University, Jinan, Shandong 250012, China; Recruiting
Ming Hou, Email: houming@medmail.com.cn
Ming Hou, Principal Investigator
Additional Information

Starting date: October 2013
Last updated: October 29, 2013

Page last updated: August 23, 2015

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