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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: |
NCT03345589 |
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Date of registration:
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06/11/2017 |
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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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A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
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Scientific title:
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A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis |
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Date of first enrolment:
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January 30, 2018 |
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Target sample size:
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40 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03345589 |
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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 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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Li Yang |
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Address:
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Telephone:
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+8618980601276 |
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Email:
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yangli_hx@scu.edu.cn |
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Affiliation:
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Name:
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Li Yang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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West China Hospital |
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Name:
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Ping Ni, MD |
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Address:
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Telephone:
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13281091993 |
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Email:
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545043216@qq.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients diagnosed with primary biliary cholangitis
- Treated with Ursodeoxycholic Acid in West China Hospital for at least 6 month and
suboptimal response to Ursodeoxycholic Acid
Exclusion Criteria:
- Autoimmune hepatitis
- Primary sclerosing cholangitis
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cholangitis
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Intervention(s)
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Drug: 18-22mg/kg/d Ursodeoxycholic
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Drug: 13-15mg/kg/d Ursodeoxycholic
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Primary Outcome(s)
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Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC)
[Time Frame: Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid]
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Secondary Outcome(s)
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Alanine transaminase
[Time Frame: Week 2 and Month 1, 3, 6]
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Aspartate transaminase
[Time Frame: Week 2 and Month 1, 3, 6, 9,12]
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Glutamyltransferase
[Time Frame: Week 2 and Month 1, 3, 6,9,12]
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Alkaline phosphatase
[Time Frame: Week 2 and Month 1, 3, 6,9,12]
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Total bilirubin
[Time Frame: Week 2 and Month 1, 3, 6, 9,12]
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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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