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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

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ClinicalTrials.gov Identifier: NCT04376528
Recruitment Status : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : May 6, 2020
Sponsor:
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

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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
Estimated Study Start Date : May 30, 2020
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



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

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 ClinicalTrials.gov identifier (NCT number): NCT04376528


Contacts
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Contact: Li Yang, Master degree +86 13518178110 yangli_hx@scu.edu.cn
Contact: Li Yang +86 13518178110 yangli_hx@scu.edu.cn

Sponsors and Collaborators
West China Hospital
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Responsible Party: Li Yang, Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT04376528    
Other Study ID Numbers: OS-3
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Cholangitis
Liver Cirrhosis, Biliary
Hepatitis, Autoimmune
Undifferentiated Connective Tissue Diseases
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
Cholestasis
Liver Cirrhosis
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Connective Tissue Diseases
Cyclosporine
Mycophenolic Acid
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs