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

Primary Purpose

Primary Biliary Cirrhosis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tauroursodeoxycholic Acid Capsules
Ursodeoxycholic Acid Capsules
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring Tauroursodeoxycholic Acid, Primary Biliary Cirrhosis, Safety, Efficacy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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:

  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

Sites / Locations

  • Beijing 302 Hospital
  • Beijing Ditan Hospital
  • Beijing Friendship Hospital
  • Beijing Youan Hospital
  • Chinese PLA General Hospital
  • Peiking University First Hosptial
  • Peking University People's Hospital
  • First Affiliated Hospital,SunYat-Sen University
  • Nanfang Hospital of Southern Medical University
  • Third Affiliated Hospital,SunYat-Sen University
  • Tongji Hospital
  • 85 Military Hospital
  • Eastern Hepatobiliary Surgery Hospital
  • Huashan Hospital
  • NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • RenJi Hospital
  • RuiJin Hospital
  • ShangHai Changzheng Hospital
  • Shanghai Public Health Clinical Center
  • Shanghai Zhongshan Hospital
  • Xijing Hospital
  • West China Hospital
  • First Affiliated Hospital Of KunMing Medical College
  • The Sixth People's Hospital of Hangzhou
  • First Affiliated Hospital of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Tauroursodeoxycholic Acid Capsules,250mg,tid.

Ursodeoxycholate acid capsules, 250mg,tid,

Outcomes

Primary Outcome Measures

The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA

Secondary Outcome Measures

ALP decline from baseline after 24 weeks treatment of TUDCA
Total bilirubin decline from baseline after 24 weeks treatment of TUDCA
GGT decline from baseline after 24 weeks treatment of TUDCA
ALT and AST decline from baseline after 24 weeks treatment of TUDCA

Full Information

First Posted
May 16, 2013
Last Updated
May 16, 2013
Sponsor
Beijing Friendship Hospital
Collaborators
Beijing Trendful Kangjian Medical Information Consulting Limited Company
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1. Study Identification

Unique Protocol Identification Number
NCT01857284
Brief Title
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
Collaborators
Beijing Trendful Kangjian Medical Information Consulting Limited Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
Keywords
Tauroursodeoxycholic Acid, Primary Biliary Cirrhosis, Safety, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Tauroursodeoxycholic Acid Capsules,250mg,tid.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Ursodeoxycholate acid capsules, 250mg,tid,
Intervention Type
Drug
Intervention Name(s)
Tauroursodeoxycholic Acid Capsules
Other Intervention Name(s)
Taurolite
Intervention Description
250mg.tid.po
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid Capsules
Other Intervention Name(s)
Ursofalk
Intervention Description
250mg.tid.po
Primary Outcome Measure Information:
Title
The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ALP decline from baseline after 24 weeks treatment of TUDCA
Time Frame
12 month
Title
Total bilirubin decline from baseline after 24 weeks treatment of TUDCA
Time Frame
12 months
Title
GGT decline from baseline after 24 weeks treatment of TUDCA
Time Frame
12 months
Title
ALT and AST decline from baseline after 24 weeks treatment of TUDCA
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Ji Jia, Doctor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing 302 Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Ditan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Youan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peiking University First Hosptial
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
First Affiliated Hospital,SunYat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Third Affiliated Hospital,SunYat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hunan
Country
China
Facility Name
85 Military Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
RenJi Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
RuiJin Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
ShangHai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Xijing Hospital
City
Xian
State/Province
Shanxi
Country
China
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
First Affiliated Hospital Of KunMing Medical College
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
The Sixth People's Hospital of Hangzhou
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
First Affiliated Hospital of Zhejiang University
City
Zhejiang
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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