Back to resultsHigh-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
Primary Purpose
Immune Thrombocytopenia
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dexamethasone
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Thalidomide, Dexamethasone, ITP
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
Sites / Locations
- Qilu hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thalidomide plus HD-Dexmamethasone
Dexamethasone
Arm Description
Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days
Dexamethasone 40 mg per day, 4 consecutive days
Outcomes
Primary Outcome Measures
Evaluation of platelet response
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia
Secondary Outcome Measures
Full Information
NCT ID
NCT01976195
First Posted
October 21, 2013
Last Updated
April 18, 2016
Sponsor
Shandong University
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT01976195
Brief Title
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No eligible patient was enrolled.
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
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
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
Thalidomide, Dexamethasone, ITP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thalidomide plus HD-Dexmamethasone
Arm Type
Experimental
Arm Description
Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone 40 mg per day, 4 consecutive days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 40 mg per day, 4 consecutive days
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Thalidomide 150mg per day, 15 consecutive days
Primary Outcome Measure Information:
Title
Evaluation of platelet response
Description
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia
Time Frame
Newly diagnosed ITP in 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Qilu hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
Learn more about this trial
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
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