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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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2 May 2016 |
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Main ID: |
NCT02642380 |
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Date of registration:
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24/12/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)
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Scientific title:
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Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02642380 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Ming Hou, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shandong University, Qilu Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80
years.
3. To show a platelet count <30 * 10^9/L, and with bleeding manifestations.
4. Willing and able to sign written informed consent.
Exclusion Criteria:
1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts
within 3 months before the screening visit.
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine,
vincristine, vinblastine, etc) within 3 months before the screening visit.
3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
5. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.
Unstable or uncontrolled disease or condition related to or impacting cardiac
function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension
or cardiac arrhythmia)
6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate
pregnancy during the study period.
7. Have a known diagnosis of other autoimmune diseases, established in the medical
history and laboratory findings with positive results for the determination of
antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct
Coombs test.
8. Patients who are deemed unsuitable for the study by the investigator.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Immune Thrombocytopenia
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Intervention(s)
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Drug: Dexamethasone (4 cycles)
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Drug: Dexamethasone (1 cycle)
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Primary Outcome(s)
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sustained response to treatment
[Time Frame: 6 months after treatment started]
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Secondary Outcome(s)
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Evaluation of early response
[Time Frame: 2 months after treatment started]
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Secondary ID(s)
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High-dose dexamethasone
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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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