Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hepatitis, Primary Biliary Cholangitis, Autoimmune

Intervention / Treatment
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* Drug: Ursodeoxycholic acid combined with total glucosides of paeony
* Drug: Ursodeoxycholic acid only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-75 years; 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; Agreed to participate in the trial, and assigned informed consent. Exclusion Criteria: The presence of hepatitis A, B, C, D, or E virus infection; Patients with presence of cirrhosis; Patients with presence of fulminant liver failure; 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; Severe disorders of other vital organs, such as severe heart failure, cancer; Parenteral administration of blood or blood products within 6 months before screening; Recent treatment with drugs having known liver toxicity; Taken part in other clinic trials within 6 months before enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ursodeoxycholic acid combined with total glucosides of paeony<br> | Drug: Ursodeoxycholic acid combined with total glucosides of paeony<br>* Ursodeoxycholic acid combined with total glucosides of paeony<br>|
| Other: Ursodeoxycholic acid only<br> | Drug: Ursodeoxycholic acid only<br>* Ursodeoxycholic acid only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical remission | The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial remission | Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN | up to 12 months | 
| Minimal response | Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN | up to 12 months | 
| Treatment failure | defined as no improvement or increase of ALT or AST serum levels | up to 12 months | 
| Side-effects | Drug related side-effects | up to 12 months | 
| Clinical symptoms | Jaundice, fatigue, itching, etc | up to 12 months | 
| Changes in the proportion of blood immune cells | percentage of T cells, DC, MDSC, Treg, Breg, plasma cells, NK, NKT | up to 12 months |