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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00668070

Acronym

ASTER

Enrollment

114

Registered

2008-04-28

Start date

2008-04-30

Completion date

2010-10-31

Last updated

2013-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Steatohepatitis

Keywords

NASH, Chronic liver disease

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

Interventions

DRUGASP9831

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
ALT	12 Weeks

Countries

Belgium, Czechia, France, Germany, Romania, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026