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
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
Sponsors
Source
Shandong University
Oversight Info
Has Dmc
Yes
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.
Overall Status
Withdrawn
Start Date
2013-10-01
Completion Date
N/A
Primary Completion Date
2014-12-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Evaluation of platelet response |
Newly diagnosed ITP in 3 months |
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Dexamethasone 40 mg per day, 4 consecutive days
Arm Group Label
Thalidomide plus HD-Dexmamethasone
Dexamethasone
Intervention Type
Drug
Intervention Name
Description
Thalidomide 150mg per day, 15 consecutive days
Arm Group Label
Thalidomide plus HD-Dexmamethasone
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
Gender
All
Minimum Age
18 Years
Maximum Age
75 Years
Healthy Volunteers
No
Location
Facility |
|
Qilu hospital, Shandong University Jinan Shandong 250012 China |
Location Countries
Country
China
Verification Date
2013-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Shandong University
Investigator Full Name
Ming Hou
Investigator Title
Professor and Director
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Thalidomide
Dexamethasone
Dexamethasone acetate
BB 1101
Arm Group
Arm Group Label
Thalidomide plus HD-Dexmamethasone
Arm Group Type
Experimental
Description
Thalidomide 150mg per day, 15 consecutive days Dexamethasone 40 mg per day, 4 consecutive days
Arm Group Label
Dexamethasone
Arm Group Type
Active Comparator
Description
Dexamethasone 40 mg per day, 4 consecutive days
Firstreceived Results Date
N/A
Why Stopped
No eligible patient was enrolled.
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
October 21, 2013
Study First Submitted Qc
October 29, 2013
Study First Posted
November 5, 2013
Last Update Submitted
April 18, 2016
Last Update Submitted Qc
April 18, 2016
Last Update Posted
April 20, 2016
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.