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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00668070
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : March 21, 2013
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Non-Alcoholic Steatohepatitis Drug: ASP9831 Drug: Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Study Start Date : April 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: ASP9831 Low Dose Drug: ASP9831

Experimental: ASP9831 Higher Dose Drug: ASP9831

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. ALT [ Time Frame: 12 Weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00668070

Antwerp, Belgium, 2650
Brussels, Belgium, 1200
Gent, Belgium, 9000
La Louviere, Belgium, 7100
Leuven, Belgium, 3000
Czech Republic
Brno-Bohunice, Czech Republic, 62500
Prague, Czech Republic, 18000
Praha, Czech Republic, 14021
Amiens Cedex 1, France
Angers cedex 9, France, 49933
Montpellier cedex 5, France, 34295
Paris Cedex 13, France, 75651
Paris, France, 75571
Pessac, France, 33604
Berlin, Germany, 13353
Essen, Germany, 45122
Frankfurt am Main, Germany, 60590
Mainz, Germany, 55101
Regensburg, Germany, 93042
Bucharest, Romania, 021105
Bucharest, Romania, 022328
Iasi, Romania, 700111
Timisoara, Romania, 300736
Basel, Switzerland, 4031
Bern, Switzerland, 3010
Zurich, Switzerland, 8091
United Kingdom
Birmingham, United Kingdom
London, United Kingdom
Newcastle upon Tyne, United Kingdom, NE77DN
Nottingham, United Kingdom, NG77DN
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use central contact Astellas Pharma Europe B.V.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00668070     History of Changes
Other Study ID Numbers: 9831-CL-0301
2007-002114-19 ( EudraCT Number )
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: March 21, 2013
Last Verified: November 2010

Keywords provided by Astellas Pharma Inc:
Chronic liver disease

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action