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UDCA VS TUDCA
DIR By: Road2HardCoreIron
Date: May 6, 2018, 11:44 am
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Study Record Detail
Save this study
Efficacy and Safety Study of TUDCA Compare UDCA to Treatment
Chronic Cholestatic Liver Disease-PBC
The safety and scientific validity of this study is the
responsibility of the study sponsor and investigators. Listing a
study does not mean it has been evaluated by the U.S. Federal
Government. Read our disclaimer for details.
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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No Results Posted
Disclaimer
How to Read a Study Record
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
Choosing to participate in a study is an important personal
decision. Talk with your doctor and family members or friends
about deciding to join a study. To learn more about this study,
you or your doctor may contact the study research staff using
the contacts provided below. For general information, Learn
About Clinical Studies.
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
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