Biochemical Response and Clinical Outcomes in Patients With PBC

NCT07449793 | Recruiting

• 1 other identifier: PBC2026CH001
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics of diagnosed PBC patients. The study aims to analyze the association between varying post-treatment alkaline phosphatase (AKP) levels and complication-free survival rates, with the objective to develop and validate a predictive survival model.

Conditions

Primary Biliary Cholangitis (PBC); Primary Biliary Cholangitis

Keywords

Primary Biliary Cirrhosis; Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholangitis, Biliary; Cirrhosis, Biliary; Chronic Nonsuppurative Destructive Cholangitis

Outcome Measures

Primary Outcomes (1)

• Rate of complication-free survival

  Complication-free survival, defined as survival without liver-related death caused by PBC, liver transplantation, or major liver-related complications (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma) during follow-up.

  18 months

Study Arms (3)

Group 1: AKP<1*ULN

Patients diagnosed with PBC whose AKP levels fall below the upper limit of normal (ULN) after 12 months of treatment.

Other: Only observation

Group 2: AKP<1.67*ULN and >1*ULN

Patients diagnosed with PBC whose AKP levels are between 1\* and 1.67\*ULN after 12 months of treatment.

Other: Only observation

Group 3: AKP>1.67*ULN

Patients diagnosed with PBC whose AKP levels exceed 1.67\*ULN after 12 months of treatment.

Other: Only observation

Interventions

Only observation OTHER

No intervention is needed.

Group 1: AKP<1*ULN; Group 2: AKP<1.67*ULN and >1*ULN; Group 3: AKP>1.67*ULN

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

This program will be conducted at a single medical center in Shanghai, Mainland China. The sample size of subjects will be 3000 PBC patients.

You may qualify if:

• Age above 18 years old, Male or Female,
• Diagnosis of PBC meeting the 2018 American Association for the Study of Liver Diseases (AASLD) Practice Guidelines criteria;
• Treatment with UDCA at a standard dose (13-15 mg/kg/day), with or without other second-line medications.

You may not qualify if:

• Co-existing liver diseases, including but not limited to: Hepatitis C virus infection; Active Hepatitis B infection (patients who are HBsAg-negative and HBeAg-negative may be considered eligible per investigator assessment);
• Autoimmune Hepatitis (AIH); Primary Sclerosing Cholangitis (PSC); Suspected or confirmed hepatocellular carcinoma;
• Female subjects who is pregnant or breastfeeding during the study;
• History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
• Poor adherence or inability to complete the study follow-up.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiong Ma, MD, PhD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Lian, MD, PhD

CONTACT

+8615800744783; sophialian24@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)