Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04376528
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : June 22, 2021
Information provided by (Responsible Party):
Li Yang, West China Hospital

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 16, 2021
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

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 )

Primary Outcome Measures :
  1. Biochemical remission [ Time Frame: 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 :
  1. Partial remission [ Time Frame: 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

  2. Minimal response [ Time Frame: up to 6 months ]
    Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN

  3. Treatment failure [ Time Frame: up to 6 months ]
    defined as no improvement or increase of ALT or AST serum levels

  4. Changes in liver stiffness [ Time Frame: up to 6 months ]
    liver stiffness will be measured by shear-wave elastography

  5. Side-effects [ Time Frame: up to 6 months ]
    Drug related side-effects

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 ;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04376528

Layout table for location contacts
Contact: Xiaoli Fan, Master degree +86 13980433451
Contact: Li Yang +86 13518178110

Layout table for location information
China, Sichuan
WestChina Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Li Yang    +86 13518178110   
Sponsors and Collaborators
West China Hospital
Layout table for additonal information
Responsible Party: Li Yang, Professor, West China Hospital Identifier: NCT04376528    
Other Study ID Numbers: OS-3
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Liver Cirrhosis, Biliary
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis, Intrahepatic
Liver Cirrhosis
Pathologic Processes
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors