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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00668070
First received: April 24, 2008
Last updated: March 19, 2013
Last verified: November 2010
  Purpose

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 Intervention Phase
Non-Alcoholic Steatohepatitis
Drug: ASP9831
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • ALT [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: April 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP9831 Low Dose Drug: ASP9831
Oral
Experimental: ASP9831 Higher Dose Drug: ASP9831
Oral
Placebo Comparator: Placebo Drug: Placebo
Oral

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668070

Locations
Belgium
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
France
Amiens Cedex 1, France
Angers cedex 9, France, 49933
Montpellier cedex 5, France, 34295
Paris, France, 75571
Paris Cedex 13, France, 75651
Pessac, France, 33604
Germany
Berlin, Germany, 13353
Essen, Germany, 45122
Frankfurt am Main, Germany, 60590
Mainz, Germany, 55101
Regensburg, Germany, 93042
Romania
Bucharest, Romania, 021105
Bucharest, Romania, 022328
Iasi, Romania, 700111
Timisoara, Romania, 300736
Switzerland
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
Investigators
Study Chair: Use central contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00668070     History of Changes
Other Study ID Numbers: 9831-CL-0301, 2007-002114-19
Study First Received: April 24, 2008
Last Updated: March 19, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Romania: National Medicines Agency
Switzerland: Swissmedic

Keywords provided by Astellas Pharma Inc:
NASH
Chronic liver disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014