Clinical trial comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of non-alcoholic fatty liver disease
- Conditions
- on-alcoholic fatty liver disease (NAFLD)MedDRA version: 18.1Level: LLTClassification code 10029530Term: Non-alcoholic fatty liverSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-004605-38-DE
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 198
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,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of two doses of norursodeoxycholic acid (norUDCA) vs. placebo for the treatment of NAFLD with or without diabetes mellitus type 2<br>;Secondary Objective: To identify efficacious norUDCA dose for the treatment of NAFLD for further evaluation in phase III;Primary end point(s): primary endpoint is the change in serum alanine aminotransferase (ALT);Timepoint(s) of evaluation of this end point: End of treatment (after 12 weeks)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): s-AST, ALT, GGT at each study visit<br>ALT/AST ratio at each study visit;Timepoint(s) of evaluation of this end point: End of treatment (after 12 weeks), some endpoints additionally at each visit