A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831
NCT ID: NCT00668070
Last Updated: 2013-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
114 participants
INTERVENTIONAL
2008-04-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ASP9831 Low Dose
ASP9831
Oral
ASP9831 Higher Dose
ASP9831
Oral
Placebo
Placebo
Oral
Interventions
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ASP9831
Oral
Placebo
Oral
Eligibility Criteria
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Inclusion Criteria
* Elevated serum ALT levels
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use central contact
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Antwerp, , Belgium
Brussels, , Belgium
Ghent, , Belgium
La Louvière, , Belgium
Leuven, , Belgium
Brno-Bohunice, , Czechia
Prague, , Czechia
Prague, , Czechia
Amiens, , France
Angers, , France
Montpellier, , France
Paris, , France
Paris, , France
Pessac, , France
Berlin, , Germany
Essen, , Germany
Frankfurt am Main, , Germany
Mainz, , Germany
Regensburg, , Germany
Bucharest, , Romania
Bucharest, , Romania
Iași, , Romania
Timișoara, , Romania
Basel, , Switzerland
Bern, , Switzerland
Zurich, , Switzerland
Birmingham, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2007-002114-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9831-CL-0301
Identifier Type: -
Identifier Source: org_study_id
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