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

NCT01829698 | Completed Phase 3 DMC

• 2 other identifiers: Trendful-TAU-0012009L05707
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholestatic Liver Disease

Keywords

tudca PBC Cholestasis tauroursodeoxycholic acid taurolite

Outcome Measures

Primary Outcomes (1)

• Efficiency is defined as the patients composition whose ALP level of serum decreased more than 25% compared to baseline at treatment for 24 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.

  48 weeks

Secondary Outcomes (1)

• The change of laboratory parameters about liver function

  48 weeks

Study Arms (2)

tauroursodeoxycholic

EXPERIMENTAL

tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal

Drug: tauroursodeoxycholic

ursodeoxycholic

ACTIVE COMPARATOR

control arm: ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal

Drug: ursodeoxycholic acid

Interventions

tauroursodeoxycholic DRUG

Testing arm: tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal

Also known as: TUDCA, Taurolite

tauroursodeoxycholic

ursodeoxycholic acid DRUG

ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal

Also known as: UDCA, Ursofalk

ursodeoxycholic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages Eligible for Study: 18 Years to 70 Years
• Alkaline phosphatase (ALP) ≥ 2 times the Upper Limits of Normal (ULN);
• 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.

You may not qualify if:

• ．in the 3 months before screening received UDCA, hormones, immunosuppressive therapy;
• ．with extrahepatic biliary obstruction;
• ．accompanied by hepatitis B virus (HBV) and hepatitis C virus (HCV) infection;
• ．laboratory screening examination :
• hemoglobin (HB): male\< 11 g/dL, female \<10 g/dL \< g/dL;
• the total white blood cell (WBC) count \< 3000/mm3;
• the absolute neutrophil count (ANC) \<1500/mm3;
• platelet (PLT) count \<50000/mm3;
• serum albumin \<3.3g/dL;
• alanine aminotransferase (ALT) ≥ 10 ULN and / or aspartate aminotransferase (AST) ≥ 10ULN;
• ALT ≥ 5 ULN and / or AST ≥ 5 ULN with immunoglobulin G (IgG) ≥ 2ULN;
• total bilirubin (T-Bil) ≥ 4 ULN;
• prothrombin time (PT) prolonged ≥ 3 seconds (limit reference value based on) or PTA ≤ 60%;
• the serum creatinine (Cr) ≥ 1.5ULN.
• ．patients with esophageal variceal or bleeding, ascites, hepatic encephalopathy or other evidence of hepatic decompensation;

Sponsors & Collaborators

• Beijing Trendful Kangjian Medical Information Consulting Limited Company: lead

Study Sites (1)

Liver Research Center,Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Interventions

ursodoxicoltaurine; Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Ji Dong Jia, Doctor

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

• 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

  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

  First Affiliated Hospital of Kunming Medical University

  STUDY DIRECTOR

• Jie Xu, Doctor

  NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 11, 2013
• Study Start: August 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

CN (1)