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

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

Study Overview

• Status: Recruiting
• Conditions: Hepatitis, Autoimmune; Immunosuppression; Primary Biliary Cholangitis
• Intervention / Treatment: Drug: Cyclosporin A; Drug: Mycophenolate Mofetil

• Study Type: Interventional
• Enrollment (Anticipated): 89
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaoli Fan, Master degree; Phone Number: +86 13980433451; Email: 13980433451@163.com
• Study Contact Backup: Name: Li Yang; Phone Number: +86 13518178110; Email: yangli_hx@scu.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • WestChina Hospital
      • Contact: Li Yang; Phone Number: +86 13518178110; Email: yangli_hx@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 )

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 3, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Hepatitis; Hepatitis A; Cholangitis; Hepatitis, Autoimmune; Liver Cirrhosis, Biliary; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Mycophenolic Acid; Cyclosporine; Cyclosporins
• Other Study ID Numbers: OS-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No