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
Anhui Medical University
The First Affiliated Hospital of Dalian Medical University
Shenzhen Second People's Hospital

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.

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.

Overall Status Withdrawn
Start Date October 2013
Primary Completion Date December 2014
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Evaluation of platelet response Newly diagnosed ITP in 3 months
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

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

Location
Facility: Qilu hospital, Shandong University
Location Countries

China

Verification Date

October 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: Professor and Director

Keywords
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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov