A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831 (ASTER)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00668070 |
|
Recruitment Status :
Completed
First Posted : April 28, 2008
Last Update Posted : March 21, 2013
|
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Alcoholic Steatohepatitis | Drug: ASP9831 Drug: Placebo | Phase 2 |
The study includes an open-label sub-study prior to the main study
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 114 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | April 2008 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | October 2010 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Non-alcoholic fatty liver disease
| Arm | Intervention/treatment |
|---|---|
| Experimental: ASP9831 Low Dose |
Drug: ASP9831
Oral |
| Experimental: ASP9831 Higher Dose |
Drug: ASP9831
Oral |
| Placebo Comparator: Placebo |
Drug: Placebo
Oral |
Primary Outcome Measures :
- ALT [ Time Frame: 12 Weeks ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668070
Locations
| Belgium | |
| Antwerp, Belgium, 2650 | |
| Brussels, Belgium, 1200 | |
| Gent, Belgium, 9000 | |
| La Louviere, Belgium, 7100 | |
| Leuven, Belgium, 3000 | |
| Czech Republic | |
| Brno-Bohunice, Czech Republic, 62500 | |
| Prague, Czech Republic, 18000 | |
| Praha, Czech Republic, 14021 | |
| France | |
| Amiens Cedex 1, France | |
| Angers cedex 9, France, 49933 | |
| Montpellier cedex 5, France, 34295 | |
| Paris Cedex 13, France, 75651 | |
| Paris, France, 75571 | |
| Pessac, France, 33604 | |
| Germany | |
| Berlin, Germany, 13353 | |
| Essen, Germany, 45122 | |
| Frankfurt am Main, Germany, 60590 | |
| Mainz, Germany, 55101 | |
| Regensburg, Germany, 93042 | |
| Romania | |
| Bucharest, Romania, 021105 | |
| Bucharest, Romania, 022328 | |
| Iasi, Romania, 700111 | |
| Timisoara, Romania, 300736 | |
| Switzerland | |
| Basel, Switzerland, 4031 | |
| Bern, Switzerland, 3010 | |
| Zurich, Switzerland, 8091 | |
| United Kingdom | |
| Birmingham, United Kingdom | |
| London, United Kingdom | |
| Newcastle upon Tyne, United Kingdom, NE77DN | |
| Nottingham, United Kingdom, NG77DN | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Use central contact | Astellas Pharma Europe B.V. |
Additional Information:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00668070 History of Changes |
| Other Study ID Numbers: |
9831-CL-0301 2007-002114-19 ( EudraCT Number ) |
| First Posted: | April 28, 2008 Key Record Dates |
| Last Update Posted: | March 21, 2013 |
| Last Verified: | November 2010 |
Keywords provided by Astellas Pharma Inc:
|
NASH Chronic liver disease |
Additional relevant MeSH terms:
|
Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases Digestive System Diseases |
Phosphodiesterase 4 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |