A clinical trial to evaluate the efficacy of biphenyl dimethyl dicarboxylate/ursodeoxycholic acid (UDEX) on serum aminotransferase level among the patients related to chronic liver disease with metabolic syndrome

Not Applicable

Recruiting

Conditions: Diseases of the digestive system

Registration Number: KCT0003908

Lead Sponsor: Inje University Haeundae Paik Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Subject should be satisfied with all the below conditions
1) Age 20 or more year old
2) Initial ALT 60 or more IU/L
3) Metabolic syndrome: include 3 or more from the below 5 conditions
? Central obesity: waist circumference =90 cm in male, =85 cm in female
? Elevated blood pressure: systolic BP =130 mmHg and/or diastolic BP =85 mmHg, or the current antihypertensive medication history
? Hyperglycemia: Fasting glucose = 100 mg/dL or the current anti-diabetic medication history
? Low HDL-cholesterol: <40 mg/dL in male, <50 mg/dL in female, or current history of medication for dyslipidemia of low HDL-cholesterolemia
?Hypertriglyceridemia: =150 mg/dL, or current history of medication for hypertriglyceridemia
4) The patients was diagnosed as chronic liver diseaes by at least one of the below findings
?One more time session of the elevated AST or ALT level 6 months before
?Fatty liver findings on ultrasonography or CT
?History of medication of hepatotonics for more than 30 days

Exclusion Criteria

Subject with any of the below condistions should be excluded in this trial
1) Initial ALT > 10×UNL (Upper Normal Limit)
2) Severe alcoholic hepatitis (Harmful alcohol intake >60 g/day in maile, >40 g/day in female, AST/ALT>1.5, total bilirubin >5 mg/dL, Meddrey discrimination function =32)
3) Acute hepatitis A?? A???
4) Uncontrolled acute or chronic HBV infection (HBV DNA >2,000 IU/mL)
5) Untreated chronic hepatitis C (anti-HCV (+) and HCV RNA (+))
6) Other chronic liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis)
7) Hereditary liver disease (Wilson disease, hemochromatosis)
8) Untreated malignancy
9) Decompensated cirrhosis
10) Drug induced liver injury or toxic hepatitis
11) Renal or heart dysfunction
12) Uncontrolled diabetic patient (HbA1c >8%)
13) Severe or uncontrolled psychiatric disorder
14) HIV positivity
15) History of organ or bone marrow transplantation
16) Pregnancy
17) Dementia or severe cognitive disorder
18) Brain infarction or Parkinson disease which prevents a daily life

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of ALT normalization

Secondary Outcome Measures

Name	Time	Method
The change of controlled attenuation parameter of FiboScan;The change of liver stiffness of FiboScan;Change of score in Chonic Liver Disease Questionnaire (CLDQ);Proportion of adverse event and severe adverse event