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

Primary Biliary Cholangitis (PBC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03188146
• Other study ID #: H&H_PBC_01
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: May 1, 2028

Study information

• Verified date: December 2022
• Source: Humanity and Health Research Centre
• Contact: George Lau, MD, PhD
• Phone: 28613777
• Email: gkklau[@]hnhmgl.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis (PBC)

Intervention

Drug:
• Ursodeoxycholic Acid
Standard care of PBC patients

Locations

Country	Name	City	State
China	Centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing, China.	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Humanity and Health Research Centre	Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications of cirrhosis	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
Secondary	Liver transplant	Whether the patients have liver transplant during the follow-up	During follow-up after a year of starting UDCA, an average of 1 year