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

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

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

NCT04376528•West China Hospital

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (1)

WestChina Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

June 16, 2021

Primary Completion Date

December 30, 2021

Completion Date

December 30, 2021

Last Updated

June 22, 2021

Enrollment

ESTIMATED participants

Conditions

Hepatitis, AutoimmunePrimary Biliary CholangitisImmunosuppression

Interventions

Cyclosporin A

DRUG

Mycophenolate Mofetil

DRUG

Contacts

Xiaoli Fan, Master degree

CONTACT

+86 13980433451 13980433451@163.com

Li Yang

CONTACT

+86 13518178110 yangli_hx@scu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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