NCT03188146

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Humanity and Health Research Centre · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	Ursodeoxycholic Acid	Standard care of PBC patients

Timeline

• Start date: 2017-05-01
• Primary completion: 2025-02-15
• Completion: 2025-02-15
• First posted: 2017-06-15
• Last updated: 2025-03-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study