Hepatitis, Autoimmune, Primary Biliary Cholangitis
Conditions
Keywords
Glucocorticoid, Ursodeoxycholic Acid
Brief summary
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.
Interventions
DRUGUrsodeoxycholic acid
Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)
DRUGUrsodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)
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 18-75 years; 2. The diagnosis of PBC is clear and does not meet the Paris criteria for diagnosing PBC overlap AIH, but it needs to meet 3xULN \< ALT \< 5xULN or 3xULN \< AST \< 5xULN or 1.3xULN \< IgG \< 2xULN, and liver pathological biopsy excludes moderate or higher interface inflammation; 3. 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 cirrhosis; 3. Patients with presence of fulminant liver failure; 4. 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; 5. Severe disorders of other vital organs, such as severe heart failure, cancer; 6. Parenteral administration of blood or blood products within 6 months before screening; 7. Recent treatment with drugs having known liver toxicity; 8. Taken part in other clinic trials within 6 months before enrollment. 9. patients with contraindications of glucocorticoid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical remission | up to 12 months | The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after treatment, per treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal response | up to 12 months | Minimal response, defined as decrease of ALT or AST serum levels but still \>2x ULN |
| Treatment failure | up to 12 months | defined as no improvement or increase of ALT or AST serum levels |
| Partial remission | up to 12 months | Partial remission, defined as ALT or AST serum levels \>1x Upper Limit of Normal (ULN) and \<2x ULN |
| percentage of immune cells | baseline and month 12 | percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT |
| Side-effects | up to 12 months | Drug related side-effects |
| ALT,AST,IgG | baseline and month 3,6,12 | serum ALT,AST and IgG levels |
Countries
China
Outcome results
None listed