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
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