Primary Biliary Cirrhosis
Conditions
Keywords
Tauroursodeoxycholic Acid, Primary Biliary Cirrhosis, Safety, Efficacy
Brief summary
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.
Interventions
DRUGTauroursodeoxycholic Acid Capsules
250mg.tid.po
250mg.tid.po
Sponsors
Beijing Trendful Kangjian Medical Information Consulting Limited Company
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
1. patients who had been treated with UDCA, immunosuppressive medications within 3 months. 2. patients who had evidence of extrahepatic biliary obstruction 3. patients coinfection with HBV or HCV 4. 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. 5. patients with evidence of decompensated liver disease(ascites, gastrointestinal bleeding, hepatic encephalopathy et al.) 6. 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. 7. Body Mass Index \>28 kg/m2 8. drug or alcohol abuse. 9. patient with severe disease of heart, lung, kidney, alimentary canal, neural system, autoimmune disease or tumor 10. patient had or on the scheduled of organ transplantation; 11. patient for whom the follow-up is considered impossible 12. pregnant or nursing woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA | 12 months |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed