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

Astellas

Status and phase: Completed; Phase 2

Conditions: Non-Alcoholic Steatohepatitis

Treatments: Drug: Placebo; Drug: ASP9831

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668070

9831-CL-0301

2007-002114-19 (EudraCT Number)

Details and patient eligibility

About

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

Full description

The study includes an open-label sub-study prior to the main study

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 3 patient groups, including a placebo group

ASP9831 Low Dose

Experimental group

Treatment:

Drug: ASP9831

ASP9831 Higher Dose

Experimental group

Treatment:

Drug: ASP9831

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo