Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy

Sponsor

West China Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04376528

Collaborator

(none)

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A

Condition or Disease	Intervention/Treatment	Phase
Hepatitis, Autoimmune Primary Biliary Cholangitis Immunosuppression	Drug: Cyclosporin A Drug: Mycophenolate Mofetil	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

89 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy

Actual Study Start Date :

Jun 16, 2021

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyclosporin A	Drug: Cyclosporin A Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A)
Active Comparator: Mycophenolate Mofetil	Drug: Mycophenolate Mofetil Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil )

Arm

Intervention/Treatment

Experimental: Cyclosporin A

Drug: Cyclosporin A

Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A)

Active Comparator: Mycophenolate Mofetil

Drug: Mycophenolate Mofetil

Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil )

Outcome Measures

Primary Outcome Measures

Biochemical remission [up to 6 months]
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.

Secondary Outcome Measures

Partial remission [up to 6 months]
Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN
Minimal response [up to 6 months]
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN
Treatment failure [up to 6 months]
defined as no improvement or increase of ALT or AST serum levels
Changes in liver stiffness [up to 6 months]
liver stiffness will be measured by shear-wave elastography
Side-effects [up to 6 months]
Drug related side-effects

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;
Patients have a nonresponse to azathioprine;
The WBC count ≥2.5x10^{9/L and platelet count ≥50x10}9/L.
Agreed to participate in the trial, and assigned informed consent;

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's disease.
Pregnant and breeding women and women of childbearing age in need of reproduction
Severe disorders of other vital organs, such as severe heart failure, cancer;
Patients with presence of renal insufficiency;
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.
Patients who are allergic to these drugs;
Uncontrolled infection and hypertension ;