Non-Alcoholic SteatohepatitisPhase 2ASTERNCT00668070
A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831
A Phase 2 study testing ASP9831 in people with Non-Alcoholic Steatohepatitis, run by Astellas Pharma Inc at 30 sites in 7 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Steatohepatitis
- What is being tested?
- ASP9831
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 30 sitesin 7 countries
- Study dates
- Apr 2008to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization
- Elevated serum ALT levels
Who cannot join
- 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)
Trial locations and contacts
30 sites in 7 countries.
30 sites in 7 countries
France6 sites
Study site
Amiens
Study site
Angers, 49933
Study site
Montpellier, 34295
Study site
Paris, 75571
Study site
Paris, 75651
Study site
Pessac, 33604
Belgium5 sites
Study site
Antwerp, 2650
Study site
Brussels, 1200
Study site
Ghent, 9000
Study site
La Louvière, 7100
Study site
Leuven, 3000
Germany5 sites
Study site
Berlin, 13353
Study site
Essen, 45122
Study site
Frankfurt am Main, 60590
Study site
Mainz, 55101
Study site
Regensburg, 93042
Romania4 sites
Study site
Bucharest, 021105
Study site
Bucharest, 022328
Study site
Iași, 700111
Study site
Timișoara, 300736
United Kingdom4 sites
Study site
Birmingham
Study site
London
Study site
Newcastle upon Tyne, NE77DN
Study site
Nottingham, NG77DN
Czechia3 sites
Study site
Brno-Bohunice, 62500
Study site
Prague, 14021
Study site
Prague, 18000
Switzerland3 sites
Study site
Basel, 4031
Study site
Bern, 3010
Study site
Zurich, 8091
About this study
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)
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
Read the detailed description
The study includes an open-label sub-study prior to the main study
- Conditions
- Non-Alcoholic Steatohepatitis
- Being tested
- ASP9831, Placebo
- Keywords
- NASH, Chronic liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP9831Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP9831 Low Dose | Experimental | Not described Receives: Drug: ASP9831 |
| ASP9831 Higher Dose | Experimental | Not described Receives: Drug: ASP9831 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALT
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use central contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668070
- Sponsor's protocol ID
- 9831-CL-0301
- Other IDs
- 2007-002114-19
- Acronym
- ASTER
- Status last verified
- Nov 2010
- First submitted
- 24 Apr 2008
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00668070
- Acronym / sponsor ID
- ASTER / 9831-CL-0301
- Conditions
- Non-Alcoholic Steatohepatitis
- Keywords
- NASH, Chronic liver disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASP9831 Low Dose | Experimental | Drug: ASP9831 |
| ASP9831 Higher Dose | Experimental | Drug: ASP9831 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization
- Elevated serum ALT levels
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP9831Oral | Drug | ASP9831 Higher Dose, ASP9831 Low Dose |
| PlaceboOral | Drug | Placebo |
Primary outcome
ALT
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use central contact study chair
Astellas Pharma Europe B.V.
30 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP9831 in people with Non-Alcoholic Steatohepatitis, run by Astellas Pharma Inc at 30 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France, Belgium, Germany, Romania, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALT (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.