Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid

Recruiting

• Conditions: Primary Biliary Cholangitis (PBC)
• Interventions: Drug: Ursodeoxycholic Acid

• Registration Number: NCT03188146
• Lead Sponsor: Humanity and Health Research Centre

Brief Summary

Several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their management. However there scoring systems have not been fully validated in Chinese population. This study is going to compare the prognostic ability of these criteria, validate the overseas scoring systems, develop and validate a new scoring system in a cohort of Chinese PBC patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-21
• Primary Completion: 2027-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• With liver biopsy proved PBC

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PBC patients with liver biopsy	Ursodeoxycholic Acid	Ursodeoxycholic acid will be given compliance to the treatment guideline.

Primary Outcome Measures

Name	Time	Method
Liver related Death	During follow-up after a year of starting UDCA, an average of 1 year	Whether the patients die from liver-related causes during the follow-up

Secondary Outcome Measures

Name	Time	Method
Complications of cirrhosis	During follow-up after a year of starting UDCA, an average of 1 year	Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up
Liver transplant	During follow-up after a year of starting UDCA, an average of 1 year	Whether the patients have liver transplant during the follow-up

Trial Locations

Locations (1)

Centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing, China.; 🇨🇳 Beijing, China