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

Sponsor

Xiaoli Fan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04933292

Collaborator

(none)

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Hepatitis Primary Biliary Cirrhosis	Drug: Methylprednisolone and Mycophenolate mofetil Drug: Methylprednisolone and azathioprine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 16, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methylprednisolone and Mycophenolate mofetil	Drug: Methylprednisolone and Mycophenolate mofetil Methylprednisolone combination of mycophenolate mofetil
Active Comparator: Methylprednisolone and Azathioprine	Drug: Methylprednisolone and azathioprine Methylprednisolone combination of azathioprine

Arm

Intervention/Treatment

Experimental: Methylprednisolone and Mycophenolate mofetil

Drug: Methylprednisolone and Mycophenolate mofetil

Methylprednisolone combination of mycophenolate mofetil

Active Comparator: Methylprednisolone and Azathioprine

Drug: Methylprednisolone and azathioprine

Methylprednisolone combination of azathioprine

Outcome Measures

Primary Outcome Measures

Biochemical remission [6 months]
The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.