A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Phosphodiesterase 4 Inhibitors

Criteria

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)