Status:
COMPLETED
A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Non-Alcoholic Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wee...
Detailed Description
The study includes an open-label sub-study prior to the main study
Eligibility Criteria
Inclusion
- NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization
- Elevated serum ALT levels
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00668070
Start Date
April 1 2008
End Date
October 1 2010
Last Update
March 21 2013
Active Locations (30)
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1
Antwerp, Belgium, 2650
2
Brussels, Belgium, 1200
3
Ghent, Belgium, 9000
4
La Louvière, Belgium, 7100