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

Sponsor

Shandong University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01976195

Collaborator

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (Other), Anhui Medical University (Other), The First Affiliated Hospital of Dalian Medical University (Other), Shenzhen Second People's Hospital (Other)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia	Drug: Dexamethasone Drug: Thalidomide	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thalidomide plus HD-Dexmamethasone Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days	Drug: Dexamethasone Dexamethasone 40 mg per day, 4 consecutive days Drug: Thalidomide Thalidomide 150mg per day, 15 consecutive days
Active Comparator: Dexamethasone Dexamethasone 40 mg per day, 4 consecutive days	Drug: Dexamethasone Dexamethasone 40 mg per day, 4 consecutive days

Arm

Intervention/Treatment

Experimental: Thalidomide plus HD-Dexmamethasone

Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days

Drug: Dexamethasone

Dexamethasone 40 mg per day, 4 consecutive days

Drug: Thalidomide

Thalidomide 150mg per day, 15 consecutive days

Active Comparator: Dexamethasone

Dexamethasone 40 mg per day, 4 consecutive days

Drug: Dexamethasone

Dexamethasone 40 mg per day, 4 consecutive days

Outcome Measures

Primary Outcome Measures

Evaluation of platelet response [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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