Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Though ursodeoxycholate acid (UDCA) is the well known effective therapy for PBC,clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.The more hydrophillic 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 ALP,total bilirubin, GGT,ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Trendful Kangjian Medical Information Consulting Limited Company
• Treatments: Taurochenodeoxycholic Acid; Tauroursodeoxycholic acid; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• 1 Ages Eligible for Study: 18 Years to 70 Years

2 Alkaline phosphatase (ALP) ≥ 2 times the Upper Limits of Normal (ULN);

3 Anti mitochondrial antibody (AMA) positive and / or anti-mitochondrial antibody subtype M2 (AMA-M2) positive; if the AMA and AMA-M2 were negative, need liver biopsy confirmed pathological changes in PBC.

Exclusion Criteria:

• 1．in the 3 months before screening received UDCA, hormones, immunosuppressive therapy;

2．with extrahepatic biliary obstruction;

3．accompanied by hepatitis B virus (HBV) and hepatitis C virus (HCV) infection;

4．laboratory screening examination :

1. hemoglobin (HB): male< 11 g/dL, female <10 g/dL < g/dL;

2. the total white blood cell (WBC) count < 3000/mm3;

3. the absolute neutrophil count (ANC) <1500/mm3;

4. platelet (PLT) count <50000/mm3;

5. serum albumin <3.3g/dL;

6. alanine aminotransferase (ALT) ≥ 10 ULN and / or aspartate aminotransferase (AST) ≥ 10ULN;

7. ALT ≥ 5 ULN and / or AST ≥ 5 ULN with immunoglobulin G (IgG) ≥ 2ULN;

8. total bilirubin (T-Bil) ≥ 4 ULN;

9. prothrombin time (PT) prolonged ≥ 3 seconds (limit reference value based on) or PTA ≤ 60%;

10. the serum creatinine (Cr) ≥ 1.5ULN.

5．patients with esophageal variceal or bleeding, ascites, hepatic encephalopathy or other evidence of hepatic decompensation;

6．diagnosed with liver cancer, suspected to have liver cancer, AFP > 100ng/ml. As the AFP in 2 times the upper limit of normal to 100ng/ml, need re-check in 2 weeks, if their AFP > 100ng/ml can not be included

7．body mass index >28 (Kg/m2);

8．alcohol or drug abusers within the recent year;

9．there is a serious heart, lung, kidney, digestive, nervous, mental disease, autoimmune diseases or malignant tumor

10．drug-induced liver injury;

11. plan to transplant or have had organ transplants;

12． are unable or unwilling to provide informed consent or fails to comply with the test requirements;

13．pregnant, lactating women.