NCT04617561

Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II

Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.

Conditions

• Hepatitis, Autoimmune
• Primary Biliary Cholangitis

Interventions

Type	Name	Description
DRUG	Ursodeoxycholic acid	Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)
DRUG	Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)	Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2020-11-05
• Last updated: 2021-03-22

Locations

1 site across 1 country: China