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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Methylprednisolone combination of mycophenolate mofetil
Methylprednisolone combination of azathioprine
West China Hospital of Sichuan Univerisity
Chengdu, Sichuan, China
RECRUITINGBiochemical remission
The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group
Time frame: 6 months
The level of IgG value in both groups
Time frame: at 1 month
The level of IgG value in both groups
Time frame: at 3-month
The level of IgG value in both groups
Time frame: at 6-month
Adverse drug reactions
Time frame: up to 6 months
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