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Completed

NCT Number: NCT03188146

Performance of 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.

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Key information

Conditions

Primary Biliary Cholangitis (PBC) Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, 86, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ursodeoxycholic acid

Drug

Standard care of PBC patients

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Collaborators

  • Beijing 302 Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2017
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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