Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
The study includes an open-label sub-study prior to the main study
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization
Elevated serum ALT levels
You may not be if
Hepatic cirrhosis
Other known cause of liver disease
Uncontrolled diabetes mellitis type 2, i.e. HbA1c \> 8.5%
Positive history of tuberculosis or a positive PPD skin test which is not explained by previous BCG vaccination
History of excessive alcohol abuse within 5 years prior to screening or a current average alcohol intake of more than 20 g/day (2 units) for females or more than 30 g/day (3 units) for males
Subject has used drugs associated with steatohepatitis within 6 months prior to screening (corticosteroids, high dose estrogens, methotrexate, amiodarone, anti-HIV drugs, tamoxifen)
