A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
Phase 4
- Conditions
- Primary Biliary Cholangitis
- Interventions
- Drug: 13-15mg/kg/d UrsodeoxycholicDrug: 18-22mg/kg/d Ursodeoxycholic
- Registration Number
- NCT03345589
- Lead Sponsor
- West China Hospital
- Brief Summary
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Patients diagnosed with primary biliary cholangitis
- Treated with Ursodeoxycholic Acid in West China Hospital for at least 6 month and suboptimal response to Ursodeoxycholic Acid
Exclusion Criteria
- Autoimmune hepatitis
- Primary sclerosing cholangitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 13-15mg/kg/d Ursodeoxycholic group 13-15mg/kg/d Ursodeoxycholic - 18-22mg/kg/d Ursodeoxycholic group 18-22mg/kg/d Ursodeoxycholic -
- Primary Outcome Measures
Name Time Method Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms.
- Secondary Outcome Measures
Name Time Method Alkaline phosphatase Week 2 and Month 1, 3, 6,9,12 (ALP)
Glutamyltransferase Week 2 and Month 1, 3, 6,9,12 (GGT)
Aspartate transaminase Week 2 and Month 1, 3, 6, 9,12 (AST)
Alanine transaminase Week 2 and Month 1, 3, 6 (ALT)
Total bilirubin Week 2 and Month 1, 3, 6, 9,12 (TB)
Trial Locations
- Locations (1)
West China Hospital
🇨🇳Chengdu, Sichuan, China