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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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21 June 2021 |
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Main ID: |
NCT03998982 |
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Date of registration:
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25/06/2019 |
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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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Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP
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Scientific title:
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A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) |
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Date of first enrolment:
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June 25, 2019 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03998982 |
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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: Double (Participant, Investigator).
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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 |
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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, 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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Name:
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Ming Hou, MD,PhD |
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Address:
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Telephone:
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+86-531-82169114 Ext. 9879 |
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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:
- Meet the diagnostic criteria for immune thrombocytopenia;
- Untreated hospitalized patients, may be male or female, between the ages of 18~ 80
years;
- To show a platelet count <30 * 10^9/L, and with bleeding manifestations;
- Willing and able to sign written informed consent
Exclusion Criteria:
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts
within 3 months before the screening visit;
- Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine,
vincristine, vinblastine, etc) within 3 months before the screening visit;
- Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study;
- Current HIV infection;
- Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.
Unstable or uncontrolled disease or condition related to or impacting cardiac
- Female patients who are nursing or pregnant, who may be pregnant, or who contemplate
pregnancy during the study period;
- 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;
- 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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Intervention(s)
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Drug: Dexamethasone
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Drug: Glycyrrhetinic Acid
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Primary Outcome(s)
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Sustained response to ITP treatments
[Time Frame: 3 months after treatment started]
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Secondary Outcome(s)
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Evaluation of platelet response
[Time Frame: 3 months after treatment started]
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Secondary ID(s)
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Glycyrrhetinic Acid+DXM 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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