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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02914054 |
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Date of registration:
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19/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone
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Scientific title:
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Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM) |
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Date of first enrolment:
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October 1, 2016 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02914054 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Iran, Islamic Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The eligible patients for this study were aged 18 or older of both genders with newly
diagnosed primary ITP according to the international working group (IWG) guideline(6).
All patients included in the study were treatment naïve ITP within 3 months from
diagnosis and a platelet count of no more the 30×10^9/L, or more than 30×10^9/L with
presence of bleeding symptoms according to the grading score of bleeding
Exclusion Criteria:
- malignancy, pregnancy or lactation, liver and kidney failure, connective tissue
disorders, seropositive detection of HIV, hepatitis B virus or hepatitis C virus or
any recent viral infection, active infection, diabetes, hypertension, cardiovascular
disorders, autoimmune hemolytic anemia, psychosis, osteoporosis, any corticosteroid or
immunosuppressive therapy in 3 months before diagnosis and any previous ITP-specific
therapy.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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ITP
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Croticosteroid Therapy
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Intervention(s)
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Drug: High dose Dexamethasone pulses
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Drug: Prednisone
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Primary Outcome(s)
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platelet count
[Time Frame: 6-12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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