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

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Capital Medical University

Status and phase

Completed
Phase 3

Conditions

Primary Biliary Cirrhosis

Treatments

Drug: Ursodeoxycholic Acid Capsules
Drug: Tauroursodeoxycholic Acid Capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT01857284
2009L05707 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

216 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

216 participants in 2 patient groups

Group 1
Experimental group
Description:
Tauroursodeoxycholic Acid Capsules,250mg,tid.
Treatment:
Drug: Tauroursodeoxycholic Acid Capsules
Group 2
Active Comparator group
Description:
Ursodeoxycholate acid capsules, 250mg,tid,
Treatment:
Drug: Ursodeoxycholic Acid Capsules

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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