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

NCT ID: NCT01976195

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Immune Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thalidomide plus HD-Dexmamethasone

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone 40 mg per day, 4 consecutive days

Thalidomide

Intervention Type DRUG

Thalidomide 150mg per day, 15 consecutive days

Dexamethasone

Dexamethasone 40 mg per day, 4 consecutive days

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 40 mg per day, 4 consecutive days

Interventions

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Dexamethasone

Dexamethasone 40 mg per day, 4 consecutive days

Intervention Type DRUG

Thalidomide

Thalidomide 150mg per day, 15 consecutive days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

OTHER

Sponsor Role collaborator

Anhui Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Ming Hou

Professor and Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qilu hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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ITP-Thalidomide

Identifier Type: -

Identifier Source: org_study_id

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