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

Shandong University

Status and phase: Withdrawn; Phase 2

Conditions: Immune Thrombocytopenia

Treatments: Drug: Dexamethasone; Drug: Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT01976195

ITP-Thalidomide

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Thalidomide plus HD-Dexmamethasone

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Drug: Thalidomide

Dexamethasone

Active Comparator group

Description:

Dexamethasone 40 mg per day, 4 consecutive days

Treatment:

Drug: Dexamethasone