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

NCT ID: NCT04376528

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2021-12-30

Brief Summary

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

Conditions

Hepatitis, Autoimmune; Primary Biliary Cholangitis; Immunosuppression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyclosporin A

Group Type: EXPERIMENTAL

Cyclosporin A

Intervention Type: DRUG

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

Mycophenolate Mofetil

Group Type: ACTIVE_COMPARATOR

Mycophenolate Mofetil

Intervention Type: DRUG

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

Interventions

Cyclosporin A

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

Intervention Type: DRUG

Mycophenolate Mofetil

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

Intervention Type: DRUG

Eligibility Criteria

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 ;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

WestChina Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoli Fan, Master degree

Role: CONTACT

13980433451@163.com

+86 13980433451

Li Yang

Role: CONTACT

yangli_hx@scu.edu.cn

+86 13518178110

Facility Contacts

Li Yang

Role: primary

yangli_hx@scu.edu.cn

+86 13518178110

Other Identifiers

OS-3

Identifier Type: -

Identifier Source: org_study_id