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

Phase 4

• Conditions: Hepatitis, Autoimmune; Primary Biliary Cholangitis; Immunosuppression
• Interventions: Drug: Cyclosporin A; Drug: Mycophenolate Mofetil

• Registration Number: NCT04376528
• Lead Sponsor: West China Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-03
• Study First Posted: 2020-05-06
• Status Verified: 2021-05
• Study Start: 2021-06-16
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-22
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

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

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's disease.
5. Pregnant and breeding women and women of childbearing age in need of reproduction
6. Severe disorders of other vital organs, such as severe heart failure, cancer;
7. Patients with presence of renal insufficiency;
8. Parenteral administration of blood or blood products within 6 months before screening;
9. Recent treatment with drugs having known liver toxicity;
10. Taken part in other clinic trials within 6 months before enrollment.
11. Patients who are allergic to these drugs;
12. Uncontrolled infection and hypertension ;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporin A	Cyclosporin A	-
Mycophenolate Mofetil	Mycophenolate Mofetil	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

WestChina Hospital; 🇨🇳 Chengdu, Sichuan, China