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

March 21, 2025 updated by: Humanity and Health Research Centre

Performance of Biochemical Response Criteria and Risk Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 86
        • Centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing, China.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with PBC who are referred to centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing from 2010 will be evaluated.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PBC patients with liver biopsy
Ursodeoxycholic acid will be given compliance to the treatment guideline.
Drug: Ursodeoxycholic Acid
Standard care of PBC patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver related Death
Time Frame: 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
During follow-up after a year of starting UDCA, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of cirrhosis
Time Frame: 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
During follow-up after a year of starting UDCA, an average of 1 year
Liver transplant
Time Frame: During follow-up after a year of starting UDCA, an average of 1 year
Whether the patients have liver transplant during the follow-up
During follow-up after a year of starting UDCA, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanity and Health Research Centre

Collaborators

Beijing 302 Hospital

Investigators

  • Principal Investigator: George Lau, MD, PhD, Humanity and Health Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

February 15, 2025

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H&H_PBC_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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