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

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.

Conditions

• Cholestatic Liver Disease

Interventions

DRUG

tauroursodeoxycholic

Testing arm: tauroursodeoxycholic 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

Sponsors & Collaborators

• Beijing Trendful Kangjian Medical Information Consulting Limited Company

  lead OTHER

Principal Investigators

• Ji Dong Jia, Doctor · Beijing Friendship Hospital

• Wen Xie, Doctor · Beijing Ditan Hospital

• Hui Ping Yan, Doctor · Beijing YouAn Hospital

• Guo Feng Chen, Doctor · Beijing 302 Hospital

• Gui Qiang Wang, Doctor · Peking University First Hospital

• Lai Wei, Doctor · Peking University People's Hospital

• Liu Fang Cheng, Doctor · Chinese PLA General Hospital

• Min De Zeng · RenJi Hospital

• Qing Xie, Doctor · Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

• Guang Feng Shi, Doctor · Affiliated HuaShan Hospital of Fudan University

• Ji Yao Wang, Doctor · Affiliated Zhongshan Hospital of Fudan University

• Xiao Hui Miao, Doctor · Shanghai Changzheng Hospital

• Cheng Wei Chen, Doctor · No.85 hospital of PLA

• Shan Ming Wu, Doctor · Shanghai Public Health Clinical Center

• He Ping Hu, Doctor · Shanghai Eastern Hepatobiliary Surgery Hospital

• Min Hu Chen, Doctor · The First Affiliated Hospital,SunYat-Sen University

• Zhi Liang Gao, Doctor · The Third Affiliated Hospital,SunYat-Sen University

• Jin Lin Hou, Doctor · Affiliated Southern Hospital of Southern Medical University

• Ji Fang Sheng, Doctor · The First Affiliated Hospital of Medical College,Zhejiang University

• Xiao Qing Fu, Doctor · NO.6 People's Hospital of Hangzhou

• Hong Tang, Doctor · Affiliated Huaxi Hospital of Sichuan University

• Ying Han, Doctor · The First Affiliated Hospital of the Fourth Military Medical University

• Qin Ning, Doctor · Affiliated TongJi Hospital Of Tongji Medical College Huazhong University Of Science&Technology

• Li Ping Duan, Doctor · First Affiliated Hospital of Kunming Medical University

• Jie Xu, Doctor · NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2013-01-31

Completion

2014-02-28

Countries

• China

Study Locations