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

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ClinicalTrials.gov Identifier: NCT01829698
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
Beijing Trendful Kangjian Medical Information Consulting Limited Company

Tracking Information
First Submitted Date  ICMJE April 9, 2013
First Posted Date  ICMJE April 11, 2013
Last Update Posted Date March 24, 2014
Study Start Date  ICMJE August 2009
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2014)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
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: 24 weeks ]
After 24 weeks of treatment ,caculate the rate of patients whose ALP level of serum ALP decreased more than 25% compared to the baseline.
Change History Complete list of historical versions of study NCT01829698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2014)
The change of laboratory parameters about liver function [ Time Frame: 48 weeks ]
  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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2013)
liver's function improved biochemical marks changes [ Time Frame: 24 weeks ]
  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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC
Official Title  ICMJE 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
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cholestatic Liver Disease
Intervention  ICMJE
  • Drug: tauroursodeoxycholic
    Testing arm: tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
    Other Names:
    • TUDCA
    • Taurolite
  • Drug: ursodeoxycholic acid
    ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal
    Other Names:
    • UDCA
    • Ursofalk
Study Arms  ICMJE
  • Experimental: tauroursodeoxycholic
    tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
    Intervention: Drug: tauroursodeoxycholic
  • Active Comparator: ursodeoxycholic
    control arm: ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal
    Intervention: Drug: ursodeoxycholic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2014)
199
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2013)
216
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01829698
Other Study ID Numbers  ICMJE Trendful-TAU-001
2009L05707 ( Other Grant/Funding Number: SFDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Trendful Kangjian Medical Information Consulting Limited Company
Study Sponsor  ICMJE Beijing Trendful Kangjian Medical Information Consulting Limited Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
Study Director: Guo Feng Chen, Doctor Beijing 302 Hospital
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
PRS Account Beijing Trendful Kangjian Medical Information Consulting Limited Company
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP