NCT06591468

A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Han Ying · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment. However, as it is not yet sufficient to diagnose autoimmune hepatitis or overlap syndrome, it is difficult to initiate immunosuppressive therapy such as steroids according to current guidelines. The aim of this study is to explore whether PBC patients with moderate to severe interfacial inflammation can benefit from UDCA combined with prednisone therapy, and its treatment safety.

Conditions

• Primary Biliary Cholangitis (PBC)

Interventions

Type	Name	Description
DRUG	Prednisone	Prednisone 30-40 mg/day, at 7am in the morning, gradually reduced after 1 month (5mg every 7-14 days) to 5-10 mg for maintenance treatment
DRUG	UDCA (Ursodeoxycholic acid)	13-15 mg/kg/day

Timeline

• Start date: 2024-10-30
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-09-19
• Last updated: 2025-11-28

Locations

2 sites across 1 country: China