Clinical trial NCT00668070: A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Alcoholic Steatohepatitis
Keywords: NASH
Chronic liver disease
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-04-28
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: ALT
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: La Louviere
country: Belgium
city: Leuven
country: Belgium
city: Brno-Bohunice
country: Czech Republic
city: Prague
country: Czech Republic
city: Praha
country: Czech Republic
city: Amiens Cedex 1
country: France
city: Angers cedex 9
country: France
city: Montpellier cedex 5
country: France
city: Paris Cedex 13
country: France
city: Paris
country: France
city: Pessac
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Frankfurt am Main
country: Germany
city: Mainz
country: Germany
city: Regensburg
country: Germany
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Zurich
country: Switzerland
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use central contact
role: STUDY_CHAIR
References: