Status:
COMPLETED
Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC
Lead Sponsor:
Beijing Trendful Kangjian Medical Information Consulting Limited Company
Conditions:
Cholestatic Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 hydrophill...
Detailed Description
This is a double-blind, randomized, parallel controlled, multicenter, clinical trial. Subjects inclusion by randomization after passing the screening, continuous administration the test drug (Taurolit...
Eligibility Criteria
Inclusion
- 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
- 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 :
- hemoglobin (HB): male\< 11 g/dL, female \<10 g/dL \< g/dL;
- the total white blood cell (WBC) count \< 3000/mm3;
- the absolute neutrophil count (ANC) \<1500/mm3;
- platelet (PLT) count \<50000/mm3;
- serum albumin \<3.3g/dL;
- alanine aminotransferase (ALT) ≥ 10 ULN and / or aspartate aminotransferase (AST) ≥ 10ULN;
- ALT ≥ 5 ULN and / or AST ≥ 5 ULN with immunoglobulin G (IgG) ≥ 2ULN;
- total bilirubin (T-Bil) ≥ 4 ULN;
- prothrombin time (PT) prolonged ≥ 3 seconds (limit reference value based on) or PTA ≤ 60%;
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT01829698
Start Date
August 1 2009
End Date
February 1 2014
Last Update
March 24 2014
Active Locations (1)
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1
Liver Research Center,Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050