EUCTR2007-002114-19-CZ
Active, not recruiting
Not Applicable
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) - ASTER
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Astellas Pharma Europe B.V.
- Enrollment
- 105
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria Part 1
- •1\. Subject has signed written informed consent prior to screening
- •2\. Subject is male or female and 18 years of age or above
- •3\. For Part 1a: Subject has NASH, fibrosis stage F3 (zone 3 perisinusoidal / pericellular
- •fibrosis and portal fibrosis with focal or extensive bridging fibrosis) histologically
- •confirmed by a liver biopsy performed within 1 year prior to first dose.
- •For Part 1b:
- •Subject has NASH, fibrosis stage F0 \- F3, histologically confirmed by a liver biopsy
- •performed within 1 year prior to randomization
- •4\. Subject has serum ALT levels at screening below 300 U/l according to central laboratory analysis
Exclusion Criteria
- •1\. Subject is diagnosed with hepatic cirrhosis
- •2\. Subject has confirmed positive HCV and / or positive HBV serology
- •3\. Subject has known genetic or secondary hemochromatosis
- •4\. Subject has other known cause of liver disease (autoimmune, viral, genetic, drug induced, alcoholic liver disease or storage disease) or drug\-induced hepatotoxicity
- •5\. Subject has an unstable metabolic condition i.e.; weight change \> 5% in the 6 months prior to screening and / or diagnosis of diabetes mellitus type 2 within 4 months prior to screening and / or initiation and subsequent continuous use of anti\-diabetic drugs (including insulin sensitizing agents), anti\-hypertensives and/or lipid lowering drugs within 4 months prior to screening
- •6\. Subject has uncontrolled diabetes mellitus type 2, i.e. HbA1c \> 8\.5%
- •7\. Subject suffers from clinically significant gastrointestinal disease, or has a history of inflammatory bowel disease (Crohn’s disease, ulcerative colitis and undetermined inflammatory colitis) or has a currently symptomatic gastric ulcer or erosive gastritis
- •8\. Irritable bowel syndrome
- •9\. Subject has known lipodystrophy
- •10\. Subject has had a malignancy in the last 10 years, except for adequately treated basal or squamous cell carcinoma of the skin
Outcomes
Primary Outcomes
Not specified
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