Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoim… (NCT04376528) | Clinical Trial Compass
UnknownPhase 4
Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy
China89 participantsStarted 2021-06-16
Plain-language summary
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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;
. Patients have a nonresponse to azathioprine;
. The WBC count ≥2.5x10\^9/L and platelet count ≥50x10\^9/L.
. Agreed to participate in the trial, and assigned informed consent;
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's disease.
. Pregnant and breeding women and women of childbearing age in need of reproduction
. Severe disorders of other vital organs, such as severe heart failure, cancer;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares mycophenolate mofetil to cyclosporin A specifically for people who didn't respond to standard therapy for PBC-autoimmune hepatitis overlap syndrome — does my case actually fit that 'nonresponse to standard therapy' criteria, and have we truly exhausted standard options before considering this?
2Since this is a Phase 4 trial, both drugs have already been approved for other uses, but what do you know about their specific safety profiles when used for PBC-autoimmune hepatitis overlap syndrome, and are there risks I should be especially watchful for given my current liver function?
3The trial measures 'biochemical remission' as its main goal — can you explain what that means in practical terms for my liver disease, and how meaningful would achieving biochemical remission actually be for my long-term health?
4The recruitment status for this trial is listed as unknown, so is it still actively enrolling patients, and if it's not available to me, are there other trials or treatment approaches for overlap syndrome nonresponders that we should be discussing instead?
5Both mycophenolate mofetil and cyclosporin A suppress the immune system — given that I'd be randomly assigned to one of them, how would you monitor me for serious infections or other complications, and what would it mean for my day-to-day life in terms of precautions or follow-up visits?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.