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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:
Beijing Trendful Kangjian Medical Information Consulting Limited Company
Information provided by (Responsible Party):
Beijing Trendful Kangjian Medical Information Consulting Limited Company

Study Details
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Study Description

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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.

Condition or disease 
Intervention/treatment 
Phase 
Cholestatic Liver Disease
Drug: tauroursodeoxycholic
Drug: ursodeoxycholic acid
Phase 3

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 Design

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Study Type  :
Interventional  (Clinical Trial)
Actual Enrollment  :
199 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date  :
August 2009
Actual Primary Completion Date  :
January 2013
Actual Study Completion Date  :
February 2014

Resource links provided by the National Library of Medicine


MedlinePlus related topics: Liver Diseases
Drug Information available for: Ursodiol
U.S. FDA Resources

Arms and Interventions

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Arm 
Intervention/treatment 
Experimental: tauroursodeoxycholic
tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
Drug: tauroursodeoxycholic
Testing arm: tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
Other Names:
TUDCA
Taurolite
Active Comparator: ursodeoxycholic
control arm: ursodeoxycholic 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
Other Names:
UDCA
Ursofalk


Outcome Measures

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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. [ 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.


Secondary Outcome Measures  :
The change of laboratory parameters about liver function [ Time Frame: 48 weeks ]
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.


Eligibility Criteria

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Information from the National Library of Medicine

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Ages Eligible for Study:   
18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   
All
Accepts Healthy Volunteers:   
No
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.
Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829698

Locations
China, Beijing
Liver Research Center,Beijing Friendship Hospital

Beijing, Beijing, China, 100050
Sponsors and Collaborators
Beijing Trendful Kangjian Medical In