A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome

Last updated: June 18, 2021
Sponsor: Xiaoli Fan
Overall Status: Active - Recruiting

Phase

4

Condition

Hepatitis

Hepatic Fibrosis

Liver Disease

Treatment

N/A

Clinical Study ID

NCT04933292
OS-2
  • Ages 18-70
  • All Genders

Study Summary

Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Several studies have documented the efficacy and safety of mycophenolate mofetil(MMF) as second-line therapy for PBC-AIH overlap. However, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18-70 years;
  2. Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
  3. Agreed to participate in the trial, and assigned informed consent;
  4. The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.

Exclusion

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 beforeenrollment;
  4. Liver damage caused by other reasons: such as primary sclerosing cholangitis,non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease.
  5. Pregnant and breeding women;
  6. Severe disorders of other vital organs, such as severe heart failure, cancer;
  7. Parenteral administration of blood or blood products within 6 months before screening;
  8. Recent treatment with drugs having known liver toxicity;
  9. Taken part in other clinic trials within 6 months before enrollment.

Study Design

Total Participants: 78
Study Start date:
June 16, 2021
Estimated Completion Date:
May 31, 2022

Connect with a study center

  • West China Hospital of Sichuan Univerisity

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

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