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

March 19, 2013 updated by: Astellas Pharma Inc

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral
Experimental: ASP9831 Low Dose
Drug: ASP9831
Oral
Experimental: ASP9831 Higher Dose
Drug: ASP9831
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ALT
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 27, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9831-CL-0301
  • 2007-002114-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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