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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01857284
• Date of registration: 16/05/2013
• Prospective Registration: No
• Primary sponsor: Beijing Friendship Hospital
• Public title: Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis no
• Scientific title: 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
• Date of first enrolment: September 2009
• Target sample size: 216
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01857284
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Dong Ji Jia, Doctor
• Affiliation: Beijing Friendship Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Drug: Tauroursodeoxycholic Acid Capsules

Drug: Ursodeoxycholic Acid Capsules

Primary Outcome(s)

The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA [Time Frame: 12 months]

Secondary Outcome(s)

ALP decline from baseline after 24 weeks treatment of TUDCA [Time Frame: 12 month]

ALT and AST decline from baseline after 24 weeks treatment of TUDCA [Time Frame: 12 months]

GGT decline from baseline after 24 weeks treatment of TUDCA [Time Frame: 12 months]

Total bilirubin decline from baseline after 24 weeks treatment of TUDCA [Time Frame: 12 months]

Secondary ID(s)

2009L05707

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beijing Trendful Kangjian Medical Information Consulting Limited Company