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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Autoimmune Hepatitis, Primary Biliary Cirrhosis

Intervention / Treatment
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* Drug: Methylprednisolone and Mycophenolate mofetil
* Drug: Methylprednisolone and azathioprine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-70 years; Diagnosed with PBC-AIH overlap syndrome according to Paris criteria; Agreed to participate in the trial, and assigned informed consent; The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L. Exclusion Criteria: The presence of hepatitis A, B, C, D, or E virus infection; Patients with presence of serious decompensated cirrhosis; Patients have a history of glucocorticoid or immunosuppressant medication before enrollment; Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease. Pregnant and breeding women; Severe disorders of other vital organs, such as severe heart failure, cancer; Parenteral administration of blood or blood products within 6 months before screening; Recent treatment with drugs having known liver toxicity; Taken part in other clinic trials within 6 months before enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone and Mycophenolate mofetil<br> | Drug: Methylprednisolone and Mycophenolate mofetil<br>* Methylprednisolone combination of mycophenolate mofetil<br>|
| Active Comparator: Methylprednisolone and Azathioprine<br> | Drug: Methylprednisolone and azathioprine<br>* Methylprednisolone combination of azathioprine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical remission | The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of IgG value in both groups |  | at 1 month | 
| The level of IgG value in both groups |  | at 3-month | 
| The level of IgG value in both groups |  | at 6-month | 
| Adverse drug reactions |  | up to 6 months |