Cholangitis, Cholestasis, Hepatitis, Autoimmune, Liver Cirrhosis, Biliary
Conditions
Brief summary
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents
Interventions
DRUGUrsodeoxycholic acid combination of immunosuppressive agents
Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with or without azathioprine)
DRUGUrsodeoxycholic Acid
Ursodeoxycholic Acid
Sponsors
Xiaoli Fan
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 18-70 years; * 2.Diagnosed with primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to Paris criteria, based on liver biopsy results obtained 3 months before screening; * 3.White blood cell count ≥2.5x10\^9/L or platelet count ≥50x10\^9/L at inclusion; * 4.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 indications for immunosuppressive treatment at inclusion: serum alanine transaminase(ALT) or aspartate transaminase(AST) ≥10 fold upper limit of normal(ULN)，or serum ALT or AST≥ 5 fold ULN and γglobulin level ≥ 2 fold ULN, or bridging necrosis or multiacinar necrosis on histological examination. * 3\. Patients with complications of cirrhosis; * 4\. Patients with previous treatment of immunosuppressive agents or traditional Chinese medicine for more than one month; * 5\. Primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or Wilson's disease confirmed by liver biopsy; * 6\. Pregnant and breeding women; * 7\. Severe disorders of other vital organs, such as severe heart failure, cancer; * 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 screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of patients that achieve biochemical remission of autoimmune hepatitis(AIH) | Month 6 during treatment with ursodeoxycholic acid only or combination therapy of immunosuppressive agents |
Secondary
| Measure | Time frame |
|---|---|
| Aspartate transaminase(AST) | Week 2 and Month 1, 3, 6 |
| Immunoglobulin G(IgG) | Week 2 and Month 1, 3, 6 |
| Globin(GLB) | Week 2 and Month 1, 3, 6 |
| Total bilirubin(TB) | Week 2 and Month 1, 3, 6 |
| Alanine transaminase (ALT) | Week 2 and Month 1, 3, 6 |
| Alkaline phosphatase(ALP) | Week 2 and Month 1, 3, 6 |
| Glutamyltransferase(GGT) | Week 2 and Month 1, 3, 6 |
| Side effects | Evaluation of side effects during the study period(6 months) |
| Direct bilirubin(DB) | Week 2 and Month 1, 3, 6 |
Countries
China
Contacts
Primary ContactXiaoli Fan, MM
Outcome results
None listed