Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of non-alcoholic fatty liver disease (NAFLD) - Norursodeoxycholic acid vs. Placebo in NAFLD

Dr. Falk Pharma GmbH0 个研究点目标入组 195 人开始时间: 2014年12月2日最近更新: 2016年11月14日

适应症

试验速览

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•1. Signed informed consent,
•2. Male or female patients = 18 and < 75years,
•6. Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control, which is defined as one which results in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method (estrogen and progestogen), or some IUDs. Women of non-childbearing potential may be included if surgically sterile or post-menopausal for at least 2 years. The investigator is responsible for determining whether the subject has this adequate birth control for study participation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 45

•4. History or presence of other concomitant liver diseases including:
•Positive hepatitis B or C serology (Hbs Ag+, anti-HBc+, anti-HCV;
•Note: Patients who present with anti-HBc+ only, may be included if they are HBV-DNA negative)
•Primary Biliary Cirrhosis (AMA-positive)
•Primary Sclerosing Cholangitis
•Wilson’s Disease
•Haemochromatosis
•Autoimmune Hepatitis
•a1AT deficiency
•Known bile duct obstruction
•Drug induced liver disease
•Suspected or proven liver cancer
•5. Treatment with any of the following drugs potentially associated with NAFLD within the last 3 months prior to baseline including amiodarone, glucocorticosteroids, nifedipin, diltiazem, anabolic steroids, valproic acid, methotrexate, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement and contraceptive use,
•11. Presence of cirrhosis > Child Pugh Score A,
•12. History or presence of hepatic decompensation (e.g. variceal bleeding, INR > 1.3), hepatic encephalopathy or poorly controlled ascites,
•15. AST or ALT > 4 x ULN,
•16. Any relevant infectious disease (e.g. active tuberculosis, HIV),
•17. Abnormal renal function (Cystatin C > 1,15 x ULN) at screening and/or at baseline visit,
•20. Any active malignant disease, or history/treatment thereof in the last five years,
•21. Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile,
•23. Existing or intended pregnancy or breast-feeding,

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