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

Primary Purpose

Cholestatic Liver Disease

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

tauroursodeoxycholic

ursodeoxycholic acid

About this trial

This is an interventional treatment trial for Cholestatic Liver Disease focused on measuring tudca PBC Cholestasis tauroursodeoxycholic acid taurolite

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Liver Research Center,Beijing Friendship Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tauroursodeoxycholic

ursodeoxycholic

Arm Description

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

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

Outcomes

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.

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

after 24 weeks of treatment, the serum level ALP decreased compared with baseline. after 24 weeks of treatment, the serum bilirubin level decreased compared with baseline. after 24 weeks of treatment, the serum level of GGT decreased compared with baseline. after 24 weeks of treatment, serum ALT, AST levels decreased compared to baseline. after 48 weeks of treatment, the serum level ALP decreased compared with 24 weeks. after 48 weeks of treatment, the serum level ALP decreased compared with baseline. after 48 weeks of treatment, the serum bilirubin level decreased compared with 24 weeks. after 48 weeks of treatment, the serum level of GGT decreased compared with 24 weeks. after 48 weeks of treatment, serum ALT, AST levels decreased compared to 24 weeks.

Full Information

NCT ID

NCT01829698

First Posted

April 9, 2013

Last Updated

March 21, 2014

Sponsor

Beijing Trendful Kangjian Medical Information Consulting Limited Company

1. Study Identification

Unique Protocol Identification Number

NCT01829698

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Trendful Kangjian Medical Information Consulting Limited Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholestatic Liver Disease

Keywords

tudca PBC Cholestasis tauroursodeoxycholic acid taurolite

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

199 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tauroursodeoxycholic

Arm Type

Experimental

Arm Description

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

Arm Title

ursodeoxycholic

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

tauroursodeoxycholic

Other Intervention Name(s)

TUDCA, Taurolite

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ursodeoxycholic acid

Other Intervention Name(s)

UDCA, Ursofalk

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

The change of laboratory parameters about liver function

Description

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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 : 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. 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.

Overall Study Officials: