Hepatitis, Autoimmune, Immunosuppression, Primary Biliary Cholangitis
Conditions
Brief summary
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A
Interventions
DRUGCyclosporin A
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A)
DRUGMycophenolate Mofetil
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil )
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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 ;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical remission | 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
| Measure | Time frame | Description |
|---|---|---|
| Partial remission | 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 |
| Minimal response | up to 6 months | Minimal response, defined as decrease of ALT or AST serum levels but still \>2x ULN |
| Treatment failure | up to 6 months | defined as no improvement or increase of ALT or AST serum levels |
| Changes in liver stiffness | up to 6 months | liver stiffness will be measured by shear-wave elastography |
| Side-effects | up to 6 months | Drug related side-effects |
Countries
China
Contacts
Primary ContactXiaoli Fan, Master degree
Backup ContactLi Yang
Outcome results
None listed