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

A randomized, double-blind, placebo-controlled 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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003908

Enrollment

Registered

2019-05-14

Start date

2018-01-31

Completion date

Unknown

Last updated

2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The subjects in intervention group is assigned to oral intake of UDEX(biphenyl-dimethyl-dicarboxylate 12.5?, ursodeoxycholic acid 50?) TID for 24 weeks. The subjects in control group is assigne

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The proportion of ALT normalization	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJeong Eun Song

Inje University Haeundae Paik Hospital

seven-n@hanmail.net+82-51-797-0206

Outcome results