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CompletedNCT03188146Updated Mar 24, 2025

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

An observational study in Primary Biliary Cholangitis (PBC), sponsored by Humanity and Health Research Centre. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Humanity and Health Research Centre · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
57
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Biliary Cholangitis (PBC)
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

Inclusion criteria

  • With liver biopsy proved PBC

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
57 participants (actual)
Patient registry
No

Groups and cohorts

  • PBC patients with liver biopsy

    Ursodeoxycholic acid will be given compliance to the treatment guideline.

    Drug: Ursodeoxycholic Acid

Interventions

  • DrugUrsodeoxycholic Acid

    Standard care of PBC patients

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What researchers measure

Primary outcomes

  1. Liver related Death

    Whether the patients die from liver-related causes during the follow-up

    Time frame: During follow-up after a year of starting UDCA, an average of 1 year

Secondary outcomes

  1. Complications of cirrhosis

    Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up

    Time frame: During follow-up after a year of starting UDCA, an average of 1 year

  2. Liver transplant

    Whether the patients have liver transplant during the follow-up

    Time frame: During follow-up after a year of starting UDCA, an average of 1 year

06

Study locations

1 site
  • Centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing, China.
    Beijing, 86, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03188146
Lead sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital
Responsible party
Sponsor
First posted
Jun 15, 2017
Start date
May 1, 2017
Primary completion
Feb 15, 2025
Completion
Feb 15, 2025
Last update
Mar 24, 2025

Study contacts

George Lau, MD, PhD
principal investigator · Humanity and Health Medical Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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