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NCT Number: NCT00668070

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

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

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Key information

Conditions

Non-alcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Antwerp, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ASP9831

Drug

Oral

Placebo

Drug

Oral

Primary outcomes

  1. ALT

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Protocol for a Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week Treatment, Adaptive Proof-of-principle Study of Twice Daily Oral Dosing of a Novel PDE4 Inhibitor (ASP9831) in Subjects With Non-alcoholic Steatohepatitis (NASH)

Acronym: ASTER

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 28, 2008
Registry last updated
Mar 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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