A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Aza… (NCT04933292) | Clinical Trial Compass
UnknownPhase 4
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
China78 participantsStarted 2021-06-16
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients aged 18-70 years;
✓. Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
✓. Agreed to participate in the trial, and assigned informed consent;
✓. The WBC count ≥2.5x10\^9/L and platelet count ≥50x10\^9/L.
Exclusion criteria
✕. The presence of hepatitis A, B, C, D, or E virus infection;
✕. Patients with presence of serious decompensated cirrhosis;
✕. Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
✕. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease.
✕. Pregnant and breeding women;
✕. Severe disorders of other vital organs, such as severe heart failure, cancer;