Nonalcoholic steatohepatitis (NASH)
Conditions
Interventions
Administration of ursodeoxycholic acid (600mg/day)for 52 weeks
Administration of ursodeoxycholic acid (1200mg/day)for 52 weeks
Sponsors
Division of Gastroenterology, Saiseikai Suita Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient of NASH with the following complications: 1)The fatty liver by diagnostic imaging 2)The glucose metabolism disorder (type 2 diabetic or IGT) 3)dyslipidemia
Exclusion criteria
Exclusion criteria: 1)During the pretreatment period, the patient treated with a choleretic drug, a glycyrrhizin-combination drug, an immunotherapeutic drug, an adrenal corticoid, a liver hydrolysate, an enhancement drug of liver function, a Saiko-prescription, a bile-acid sequestrant, a phlebotomy or a folk medicine which may affect the target disorder. 2)During the pretreatment period, the patient with a discontinuation, an alternation of dose or dosage regimen, or a new additional dosage of the following drug: a) Antidiabetic drugs: an insulin preparation, a SU drug, a biguanide, an alpha-gluosidase inhibitor, a drug for postprandial hyperglycemia of the early phase, a DPP4 inhibitor, b) Anti-oxidants: a vitamin E preparation, a N-Accetyl-Cysteine preparation, c) Hypolipidemic drugs: a fibrate, a HMG-CoA reductase inhibitor, a probucol, an EPA capsule, an intestinal cholesterol-transporter inhibitor, d) Anti-hypertensive drugs: an angiotensin II receptor type-1 antagonist (ARB). 3)The patient with type1 or 2 of the Matteoni classification from biopsy examination. 4)The patient with cirrhosis diagnosed from biopsy examination (diagnosis as F4 from liver biopsy). 5)The patient in cancer therapy. 6)The patient with complete biliary atresia. 7)The patient in therapy of fulminant hepatitis. 8)The patient during pregnancy, feeding, intimation of pregnancy or intended pregnancy. 9)The patient with history of hypersensitivity to test drug 10)The patient who was diagnosed as an inappropriate one by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Histological change in liver biopsies 2) Functional change in liver enzymes 3) Safety | — |
Countries
Japan
Outcome results
None listed