Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II

Study Overview
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Brief Summary
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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.

Official Title
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Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II：A Randomized Controlled Open-label Clinical Trial

Conditions
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Hepatitis, Autoimmune, Primary Biliary Cholangitis

Intervention / Treatment
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* Drug: Ursodeoxycholic acid
* Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)


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 3xULN < ALT < 5xULN or 3xULN < AST < 5xULN or 1.3xULN < IgG < 2xULN, 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. patients with contraindications of glucocorticoid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Ursodeoxycholic Acid group<br>Ursodeoxycholic Acid 13-15mg/kg/d | Drug: Ursodeoxycholic acid<br>* Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)<br>* Other names: UDCA;Ursofalk(250mg*25,Losan Pharma GmbH);|
| Experimental: Ursodeoxycholic Acid+Low Dose Glucocorticoid group<br>Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period | Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)<br>* Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)<br>* Other names: Medrol（4mg*30,pfizer ltalia srl);|

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 treatment, per treatment group. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial remission | Partial remission, defined as ALT or 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 | 
| ALT,AST,IgG | serum ALT,AST and IgG levels | baseline and month 3,6,12 | 
| percentage of immune cells | percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT | baseline and month 12 | 
| Side-effects | Drug related side-effects | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucocorticoid, Ursodeoxycholic Acid