NCT04933292

A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Xiaoli Fan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Several studies have documented the efficacy and safety of mycophenolate mofetil(MMF) as second-line therapy for PBC-AIH overlap. However, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.

Conditions

• Autoimmune Hepatitis
• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Methylprednisolone and Mycophenolate mofetil	Methylprednisolone combination of mycophenolate mofetil
DRUG	Methylprednisolone and azathioprine	Methylprednisolone combination of azathioprine

Timeline

• Start date: 2021-06-16
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2021-06-21
• Last updated: 2021-06-21

Locations

1 site across 1 country: China