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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2022-05-31

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.

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Detailed Description

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Conditions

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Autoimmune Hepatitis Primary Biliary Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methylprednisolone and Mycophenolate mofetil

Group Type EXPERIMENTAL

Methylprednisolone and Mycophenolate mofetil

Intervention Type DRUG

Methylprednisolone combination of mycophenolate mofetil

Methylprednisolone and Azathioprine

Group Type ACTIVE_COMPARATOR

Methylprednisolone and azathioprine

Intervention Type DRUG

Methylprednisolone combination of azathioprine

Interventions

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Methylprednisolone and Mycophenolate mofetil

Methylprednisolone combination of mycophenolate mofetil

Intervention Type DRUG

Methylprednisolone and azathioprine

Methylprednisolone combination of azathioprine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18-70 years;
2. Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
3. Agreed to participate in the trial, and assigned informed consent;
4. The WBC count ≥2.5x10\^9/L and platelet count ≥50x10\^9/L.

Exclusion Criteria

1. The presence of hepatitis A, B, C, D, or E virus infection;
2. Patients with presence of serious decompensated cirrhosis;
3. Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease.
5. Pregnant and breeding women;
6. Severe disorders of other vital organs, such as severe heart failure, cancer;
7. Parenteral administration of blood or blood products within 6 months before screening;
8. Recent treatment with drugs having known liver toxicity;
9. Taken part in other clinic trials within 6 months before enrollment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No