Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis

Study Overview
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Brief Summary
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Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation. The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of UDCA, and has been approved by state food and drug administration in China for treatment of cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded, double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.

Official Title
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A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary Cirrhosis

Conditions
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Primary Biliary Cirrhosis

Intervention / Treatment
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* Drug: Tauroursodeoxycholic Acid Capsules
* Drug: Ursodeoxycholic Acid Capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent aged 18-70 years increase in alkaline phosphatase for 2 folds or more positive anti-mitochondrial antibody (AMA) with presence of antibodies against the pyruvate dehydrogenase complex (AMA-M2)；AMA-negative patients should be diagnosed as PBC with histologic evidence. Exclusion Criteria: patients who had been treated with UDCA, immunosuppressive medications within 3 months. patients who had evidence of extrahepatic biliary obstruction patients coinfection with HBV or HCV patients with one of the followings: 1) hemoglobin(HB): <11 g/dl in male, <10 g/dl in female 2) white blood cell count <3000/mm3 3) neutrophile granulocyte <1500/mm3 4) platelet <50000/mm3; 5) serum albumin <3.3 g/dl 6) alanine aminotransferase(ALT)≥10×ULN and/or aspartate aminotransferase(ALT)≥10×ULN; 7) ALT≥5×ULN and/or AST≥5×ULN coexisting with immunoglobulin G (IgG) ≥2×ULN; 8) total bilirubin ≥4×ULN; 9) prothrombin time (PT) prolong 3 seconds or more, or PTA ≦60%; 10) creatinine ≥4×ULN. patients with evidence of decompensated liver disease(ascites, gastrointestinal bleeding, hepatic encephalopathy et al.) definitely diagnosed as hepatocellular carcinoma(HCC), probable HCC, AFP>100ng/ml.Patients with AFP>2×ULN while <100ng/ml should re-test 2 weeks later. Body Mass Index >28 kg/m2 drug or alcohol abuse. patient with severe disease of heart, lung, kidney, alimentary canal, neural system, autoimmune disease or tumor patient had or on the scheduled of organ transplantation; patient for whom the follow-up is considered impossible pregnant or nursing woman

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Tauroursodeoxycholic Acid Capsules,250mg,tid. | Drug: Tauroursodeoxycholic Acid Capsules<br>* 250mg.tid.po<br>* Other names: Taurolite;|
| Active Comparator: Group 2<br>Ursodeoxycholate acid capsules, 250mg,tid, | Drug: Ursodeoxycholic Acid Capsules<br>* 250mg.tid.po<br>* Other names: Ursofalk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALP decline from baseline after 24 weeks treatment of TUDCA |  | 12 month | 
| Total bilirubin decline from baseline after 24 weeks treatment of TUDCA |  | 12 months | 
| GGT decline from baseline after 24 weeks treatment of TUDCA |  | 12 months | 
| ALT and AST decline from baseline after 24 weeks treatment of TUDCA |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tauroursodeoxycholic Acid, Primary Biliary Cirrhosis, Safety, Efficacy