Autoimmune Hepatitis, Primary Biliary Cirrhosis
Conditions
Brief 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.
Interventions
DRUGMethylprednisolone and Mycophenolate mofetil
Methylprednisolone combination of mycophenolate mofetil
DRUGMethylprednisolone and azathioprine
Methylprednisolone combination of azathioprine
Sponsors
Xiaoli Fan
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. 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 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical remission | 6 months | The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group |
Secondary
| Measure | Time frame |
|---|---|
| The level of IgG value in both groups | at 1 month |
| Adverse drug reactions | up to 6 months |
Countries
China
Contacts
Primary ContactXiaoli Fan, Master degree
Outcome results
None listed