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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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12 December 2020 |
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Main ID: |
NCT02556814 |
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Date of registration:
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21/09/2015 |
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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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Caffeic Acid Combining High-dose Dexamethasone in Management of ITP
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Scientific title:
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A Prospective, Multicenter, Placebo Controlled Study on Caffeic Acid Tablet Combining High-dose Dexamethasone in Management of Adult Primary Immune Thrombocytopenia (ITP) |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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214 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02556814 |
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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, 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:
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: placebo
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Drug: Dexamethasone
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Drug: Caffeic acid tablets
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Primary Outcome(s)
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sustained response to ITP treatments
[Time Frame: 6 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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ITP-Caffeic acid + HD-DXM
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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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