Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beijing Trendful Kangjian Medical Information Consulting Limited Company
ClinicalTrials.gov Identifier:
NCT01829698
First received: April 9, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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 hydrophillic 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 ALP,total bilirubin, GGT,ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.


Condition Intervention Phase
Cholestatic Liver Disease
Drug: tauroursodeoxycholic
Drug: ursodeoxycholic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluate the Efficacy And Safety Of TUDCA Compare UDCA In The Treatment Of Cholestatic Liver Disease-PBC by A Randomized,Double-Blind,Double Dummy,Parallel-Controlled,Multicenter Trial and The Consecutive Treatment By TUDCA

Resource links provided by NLM:


Further study details as provided by Beijing Trendful Kangjian Medical Information Consulting Limited Company:

Primary Outcome Measures:
  • Efficiency is defined as the patients composition whose ALP level of serum decreased more than 25% compared to baseline at treatment for 24 weeks. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    After 24 weeks of treatment, calculate the rate of patients whose ALP level of serum ALP decreased more than 25% compared to the baseline. After 48 weeks of treatment, calculate the rate of patients whose ALP level of serum ALP decreased more than 40% compared to the baseline.


Secondary Outcome Measures:
  • The change of laboratory parameters about liver function [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    1. after 24 weeks of treatment, the serum level ALP decreased compared with baseline.
    2. after 24 weeks of treatment, the serum bilirubin level decreased compared with baseline.
    3. after 24 weeks of treatment, the serum level of GGT decreased compared with baseline.
    4. after 24 weeks of treatment, serum ALT, AST levels decreased compared to baseline.
    5. after 48 weeks of treatment, the serum level ALP decreased compared with 24 weeks.
    6. after 48 weeks of treatment, the serum level ALP decreased compared with baseline.
    7. after 48 weeks of treatment, the serum bilirubin level decreased compared with 24 weeks.
    8. after 48 weeks of treatment, the serum level of GGT decreased compared with 24 weeks.
    9. after 48 weeks of treatment, serum ALT, AST levels decreased compared to 24 weeks.


Enrollment: 199
Study Start Date: August 2009
Study Completion Date: February 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tauroursodeoxycholic
tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
Drug: tauroursodeoxycholic
Testing arm: tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
Other Names:
  • TUDCA
  • Taurolite
Active Comparator: ursodeoxycholic
control arm: ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal
Drug: ursodeoxycholic acid
ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal
Other Names:
  • UDCA
  • Ursofalk

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 (Taurolite) or control drug (Ursofalk) treatment for 24 weeks. Compare the safety and efficacy of Taurolite vs Ursofalk.

At the end of the double-blind period,enroll 100 subjects from both two group randomly ,for a consecutive treatment use TUDCA up to 24 weeks. Further evaluate the efficacy and safety of tauroursodeoxycholic acid (TUDCA) in the treatment of adult primary biliary cirrhosis (PBC) for a long time up to one year. Also evaluate the regimen's efficacy and safety that udca take placed by TUDCA in the treatment of adult primary biliary cirrhosis (PBC) for the patients who use udca treatment for 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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 :

    1. hemoglobin (HB): male< 11 g/dL, female <10 g/dL < g/dL;
    2. the total white blood cell (WBC) count < 3000/mm3;
    3. the absolute neutrophil count (ANC) <1500/mm3;
    4. platelet (PLT) count <50000/mm3;
    5. serum albumin <3.3g/dL;
    6. alanine aminotransferase (ALT) ≥ 10 ULN and / or aspartate aminotransferase (AST) ≥ 10ULN;
    7. ALT ≥ 5 ULN and / or AST ≥ 5 ULN with immunoglobulin G (IgG) ≥ 2ULN;
    8. total bilirubin (T-Bil) ≥ 4 ULN;
    9. prothrombin time (PT) prolonged ≥ 3 seconds (limit reference value based on) or PTA ≤ 60%;
    10. 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01829698

Locations
China, Beijing
Liver Research Center,Beijing Friendship Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Beijing Trendful Kangjian Medical Information Consulting Limited Company
Investigators
Principal Investigator: Ji Dong Jia, Doctor Beijing Friendship Hospital
Study Director: Wen Xie, Doctor Beijing Ditan Hospital
Study Director: Hui Ping Yan, Doctor Beijing YouAn Hospital Capital Medical University
Study Director: Guo Feng Chen, Doctor 302 Military Hospital Of China
Study Director: Gui Qiang Wang, Doctor Peking University First Hospital
Study Director: Lai Wei, Doctor Peking University People's Hospital
Study Director: Liu Fang Cheng, Doctor Chinese PLA General Hospital
Study Director: Min De Zeng RenJi Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Study Director: Qing Xie, Doctor RuiJin Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Study Director: Guang Feng Shi, Doctor Affiliated HuaShan Hospital of Fudan University
Study Director: Ji Yao Wang, Doctor Affiliated Zhongshan Hospital of Fudan University
Study Director: Xiao Hui Miao, Doctor Shanghai Changzheng Hospital
Study Director: Cheng Wei Chen, Doctor No.85 hospital of PLA
Study Director: Shan Ming Wu, Doctor Shanghai Public Health Clinical Center
Study Director: He Ping Hu, Doctor Shanghai Eastern Hepatobiliary Surgery Hospital
Study Director: Min Hu Chen, Doctor The First Affiliated Hospital,SunYat-Sen University
Study Director: Zhi Liang Gao, Doctor The Third Affiliated Hospital,SunYat-Sen University
Study Director: Jin Lin Hou, Doctor Affiliated Southern Hospital of Southern Medical University
Study Director: Ji Fang Sheng, Doctor The First Affiliated Hospital of Medical College,Zhejiang University
Study Director: Xiao Qing Fu, Doctor NO.6 People's Hospital of Hangzhou
Study Director: Hong Tang, Doctor Affiliated Huaxi Hospital of Sichuan University
Study Director: Ying Han, Doctor The First Affiliated Hospital Of The Fourth Military Medical University
Study Director: Qin Ning, Doctor Affiliated TongJi Hospital Of Tongji Medical College Huazhong University Of Science&Technology
Study Director: Li Ping Duan, Doctor The First Affiliated Hospital of Kunming Medical College
Study Director: Jie Xu, Doctor NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Beijing Trendful Kangjian Medical Information Consulting Limited Company
ClinicalTrials.gov Identifier: NCT01829698     History of Changes
Other Study ID Numbers: Trendful-TAU-001, 2009L05707
Study First Received: April 9, 2013
Last Updated: March 21, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Trendful Kangjian Medical Information Consulting Limited Company:
tudca PBC Cholestasis tauroursodeoxycholic acid taurolite

Additional relevant MeSH terms:
Liver Diseases
Cholestasis
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Ursodeoxycholic Acid
Tauroursodeoxycholic acid
Taurochenodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 17, 2014