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

NCT03188146 | Completed FDA Drug

• 1 other identifier: H&H_PBC_01
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cholangitis (PBC)

Outcome Measures

Primary Outcomes (1)

• Liver related Death

  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 Outcomes (2)

• Complications of cirrhosis

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

• Liver transplant

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

Study Arms (1)

PBC patients with liver biopsy

Ursodeoxycholic acid will be given compliance to the treatment guideline.

Drug: Ursodeoxycholic Acid

Interventions

Ursodeoxycholic Acid DRUG

Standard care of PBC patients

PBC patients with liver biopsy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• With liver biopsy proved PBC

You may not qualify if:

• 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.

Sponsors & Collaborators

• Humanity and Health Research Centre: lead
• Beijing 302 Hospital: collaborator

Study Sites (1)

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

Beijing, 86, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• George Lau, MD, PhD

  Humanity and Health Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 15, 2017
• Study Start: May 1, 2017
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CN (1)