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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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9 January 2023 |
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Main ID: |
NCT03188146 |
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Date of registration:
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08/06/2017 |
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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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Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
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Scientific title:
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Performance of Biochemical Response Criteria and Risk Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid |
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Date of first enrolment:
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May 1, 2017 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03188146 |
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Study type:
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Observational |
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Study design:
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Phase:
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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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George Lau, MD, PhD |
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Address:
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Telephone:
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28613777 |
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Email:
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gkklau@hnhmgl.com |
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Affiliation:
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Name:
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Ang Huang, MD |
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Address:
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Telephone:
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Email:
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duanzpyouan@gmail.com |
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Affiliation:
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Name:
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George Lau, 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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Humanity and Health Medical Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- With liver biopsy proved PBC
Exclusion Criteria:
- A positive serological test for hepatitis B or C virus,
- Comorbidity of primary sclerosing cholangitis,
- Alcoholic liver disease,
- Hemochromatosis,
- Wilson's disease,
- a1-antitrypsin deficiency
- Presence of complications of cirrhosis (Total bilirubin >100 lmol/L, ascites, variceal
haemorrhage and hepatic encephalopathy) on admission.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cholangitis (PBC)
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Intervention(s)
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Drug: Ursodeoxycholic Acid
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Primary Outcome(s)
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Liver related Death
[Time Frame: During follow-up after a year of starting UDCA, an average of 1 year]
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Secondary Outcome(s)
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Liver transplant
[Time Frame: During follow-up after a year of starting UDCA, an average of 1 year]
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Complications of cirrhosis
[Time Frame: During follow-up after a year of starting UDCA, an average of 1 year]
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Secondary ID(s)
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H&H_PBC_01
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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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