Status:
COMPLETED
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
Lead Sponsor:
Beijing Friendship Hospital
Collaborating Sponsors:
Beijing Trendful Kangjian Medical Information Consulting Limited Company
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 hydrophil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01857284
Start Date
September 1 2009
End Date
January 1 2013
Last Update
May 20 2013
Active Locations (25)
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1
Beijing 302 Hospital
Beijing, Beijing Municipality, China
2
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
3
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
4
Beijing Youan Hospital
Beijing, Beijing Municipality, China