Autoimmune, Hepatitis, Primary Biliary Cholangitis
Conditions
Brief summary
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1
Interventions
DRUGUrsodeoxycholic acid combined with total glucosides of paeony
Ursodeoxycholic acid combined with total glucosides of paeony
DRUGUrsodeoxycholic acid only
Ursodeoxycholic acid only
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 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 1.0xULN \< ALT ≤ 3.0xULN or 1.0xULN \< AST ≤ 3.0xULN or 1.0xULN \< IgG ≤ 1.3xULN, 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; 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. 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 | up to 12 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 |
|---|---|---|
| Clinical symptoms | up to 12 months | Jaundice, fatigue, itching, etc |
| Changes in the proportion of blood immune cells | up to 12 months | percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT |
| Side-effects | up to 12 months | Drug related side-effects |
| 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 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels \>1x Upper Limit of Normal (ULN) and \<2x ULN |
Countries
China
Contacts
Primary ContactMengyi Shen, MD
Backup ContactLi Yang, MD
Outcome results
None listed