search
Back to results

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

Primary Purpose

Non-Alcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ASP9831
Placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Steatohepatitis focused on measuring NASH, Chronic liver disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ASP9831 Low Dose

ASP9831 Higher Dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

ALT

Secondary Outcome Measures

Full Information

First Posted
April 24, 2008
Last Updated
March 19, 2013
Sponsor
Astellas Pharma Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT00668070
Brief Title
A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831
Acronym
ASTER
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Steatohepatitis
Keywords
NASH, Chronic liver disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP9831 Low Dose
Arm Type
Experimental
Arm Title
ASP9831 Higher Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ASP9831
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
ALT
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use central contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Brno-Bohunice
ZIP/Postal Code
62500
Country
Czech Republic
City
Prague
ZIP/Postal Code
18000
Country
Czech Republic
City
Praha
ZIP/Postal Code
14021
Country
Czech Republic
City
Amiens Cedex 1
Country
France
City
Angers cedex 9
ZIP/Postal Code
49933
Country
France
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75571
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
City
Mainz
ZIP/Postal Code
55101
Country
Germany
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
City
Iasi
ZIP/Postal Code
700111
Country
Romania
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
City
Birmingham
Country
United Kingdom
City
London
Country
United Kingdom
City
Newcastle upon Tyne
ZIP/Postal Code
NE77DN
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG77DN
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=554
Description
Link to results on JAPIC

Learn more about this trial

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

We'll reach out to this number within 24 hrs