A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831
- Registration Number
- NCT00668070
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The aim of this study is to explore the effect of a new drug (ASP9831) in patients with non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period
- Detailed Description
The study includes an open-label sub-study prior to the main study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
- NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization
- Elevated serum ALT levels
Exclusion Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP9831 Low Dose ASP9831 - ASP9831 Higher Dose ASP9831 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method ALT 12 Weeks
- Secondary Outcome Measures
Name Time Method