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

NCT ID: NCT01829698

Last Updated: 2014-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-02-28

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.

Conditions

Cholestatic Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tauroursodeoxycholic

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

Group Type: EXPERIMENTAL

tauroursodeoxycholic

Intervention Type: DRUG

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

ursodeoxycholic

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

Group Type: ACTIVE_COMPARATOR

ursodeoxycholic acid

Intervention Type: DRUG

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

Interventions

tauroursodeoxycholic

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

Intervention Type: DRUG

ursodeoxycholic acid

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

Intervention Type: DRUG

Other Intervention Names

TUDCA; Taurolite; UDCA; Ursofalk

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Trendful Kangjian Medical Information Consulting Limited Company

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ji Dong Jia, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Wen Xie, Doctor

Role: STUDY_DIRECTOR

Beijing Ditan Hospital

Hui Ping Yan, Doctor

Role: STUDY_DIRECTOR

Beijing YouAn Hospital

Guo Feng Chen, Doctor

Role: STUDY_DIRECTOR

Beijing 302 Hospital

Gui Qiang Wang, Doctor

Role: STUDY_DIRECTOR

Peking University First Hospital

Lai Wei, Doctor

Role: STUDY_DIRECTOR

Peking University People's Hospital

Liu Fang Cheng, Doctor

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Min De Zeng

Role: STUDY_DIRECTOR

RenJi Hospital

Qing Xie, Doctor

Role: STUDY_DIRECTOR

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Guang Feng Shi, Doctor

Role: STUDY_DIRECTOR

Affiliated HuaShan Hospital of Fudan University

Ji Yao Wang, Doctor

Role: STUDY_DIRECTOR

Affiliated Zhongshan Hospital of Fudan University

Xiao Hui Miao, Doctor

Role: STUDY_DIRECTOR

Shanghai Changzheng Hospital

Cheng Wei Chen, Doctor

Role: STUDY_DIRECTOR

No.85 hospital of PLA

Shan Ming Wu, Doctor

Role: STUDY_DIRECTOR

Shanghai Public Health Clinical Center

He Ping Hu, Doctor

Role: STUDY_DIRECTOR

Shanghai Eastern Hepatobiliary Surgery Hospital

Min Hu Chen, Doctor

Role: STUDY_DIRECTOR

The First Affiliated Hospital,SunYat-Sen University

Zhi Liang Gao, Doctor

Role: STUDY_DIRECTOR

The Third Affiliated Hospital,SunYat-Sen University

Jin Lin Hou, Doctor

Role: STUDY_DIRECTOR

Affiliated Southern Hospital of Southern Medical University

Ji Fang Sheng, Doctor

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Medical College,Zhejiang University

Xiao Qing Fu, Doctor

Role: STUDY_DIRECTOR

NO.6 People's Hospital of Hangzhou

Hong Tang, Doctor

Role: STUDY_DIRECTOR

Affiliated Huaxi Hospital of Sichuan University

Ying Han, Doctor

Role: STUDY_DIRECTOR

The First Affiliated Hospital of the Fourth Military Medical University

Qin Ning, Doctor

Role: STUDY_DIRECTOR

Affiliated TongJi Hospital Of Tongji Medical College Huazhong University Of Science&Technology

Li Ping Duan, Doctor

Role: STUDY_DIRECTOR

First Affiliated Hospital of Kunming Medical University

Jie Xu, Doctor

Role: STUDY_DIRECTOR

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

Locations

Liver Research Center,Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2009L05707

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Trendful-TAU-001

Identifier Type: -

Identifier Source: org_study_id