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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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13 September 2021 |
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Main ID: |
NCT03692754 |
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Date of registration:
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29/09/2018 |
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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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Atorvastatin in Management of Newly Diagnosed ITP
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Scientific title:
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A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) |
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Date of first enrolment:
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November 1, 2021 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03692754 |
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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: None (Open Label).
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Phase:
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Phase 2/Phase 3
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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 |
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Address:
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Telephone:
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Email:
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houming@medmail.com.cn |
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Affiliation:
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Name:
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Ming Hou, Dr |
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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 |
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Name:
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Ming Hou, Dr |
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Address:
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Telephone:
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+86-531-82169114 |
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Email:
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houming@medmail.com.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Meet the diagnostic criteria for immune thrombocytopenia.
2. within 3 months from diagnosis,untreated patients, may be male orfemale, between the
ages of 18 ~ 80 years.
3. To show a platelet count > 30×10^9/L and without bleeding manifestations.
Exclusion Criteria:
1. Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts
within 3 months before the screening visit.
2. Received steroids or other effective therapy for immune thrombocytopenia.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
4. Severe medical condition (lung, hepatic or renal disorder) other than ITP.
5. 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:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Immune Thrombocytopenia
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Purpura, Thrombocytopenic
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Intervention(s)
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Drug: Dexamethasone
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Drug: Atorvastatin 20mg
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Drug: Atorvastatin 10mg
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Primary Outcome(s)
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Evaluation of platelet response
[Time Frame: up to 1 year per subject]
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Secondary Outcome(s)
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Therapy associated adverse events
[Time Frame: up to 1 year per subject]
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Secondary ID(s)
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Atorvastatin in ITP
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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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