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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2025-02-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Biliary Cholangitis (PBC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PBC patients with liver biopsy

Ursodeoxycholic acid will be given compliance to the treatment guideline.

Ursodeoxycholic Acid

Intervention Type DRUG

Standard care of PBC patients

Interventions

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Ursodeoxycholic Acid

Standard care of PBC patients

Intervention Type DRUG

Eligibility 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No