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

Humanity and Health Research Centre

Status: Completed

Conditions: Primary Biliary Cholangitis (PBC)

Treatments: Drug: Ursodeoxycholic Acid

Study type: Observational

Funder types: Other

Identifiers

NCT03188146

H&H_PBC_01

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

57 participants in 1 patient group

PBC patients with liver biopsy

Description:

Ursodeoxycholic acid will be given compliance to the treatment guideline.

Treatment:

Drug: Ursodeoxycholic Acid

Sponsor of this trial

Lead Sponsor

Humanity and Health Research Centre

Collaborating Sponsor

Beijing 302 Hospital