NCT06591468View on ClinicalTrials.gov

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

PHASE2/PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

244

Participants

Timeline

Start Date

October 30, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Primary Biliary Cholangitis (PBC)
Interventions
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

Trial Locations (2)

710032

Xijing hospital, Xi'an

Unknown

Sun Yat-sen Memorial Hospital, Guangzhou

All Listed Sponsors
lead

Han Ying

OTHER