SteatohepatitisPhase 2NCT01154985
Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
A Phase 2 study testing EPA-E 300 mg capsule in people with Steatohepatitis, run by Mochida Pharmaceutical Company, Ltd. at 34 sites in 2 countries.
Trial summary
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Steatohepatitis
- What is being tested?
- EPA-E 300 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Jun 2010to Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of definite NASH
- Patients with diabetes taking stable doses of anti-diabetic agents are eligible
- No significant concomitant medical illness
Who cannot join
- Diagnosis of cirrhosis.
- Serum ALT > 300 U/L
- Use of drugs associated with steatohepatitis
- Use of the following anit-NASH agents:
- Vitamin E > 60 IU per day
- Omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements > 200 mg per day
Show all 9Show fewer
- Thiazolidinediones (e.g. pioglitazone)
- Use of non-stable doses of the following anti-NASH agents: HMGCoA reductase inhibitors (statins), fibrates, probucol, ezetimibe, ursodiol (UDCA), taurine, betaine, N-acetylcysteine, s-adenosylmethionine (SAM-E), milk thistle, anti-TNF therapies, or probiotics.
- Other liver disease
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States33 sites
Mochida Investigative Site
Anaheim, California, 92801
Mochida Investigative Site
Asheville, North Carolina, 28801
Mochida Investigative Site
Chevy Chase, Maryland, 20815
Mochida Investigative Site
Chicago, Illinois, 60612
Mochida Investigative Site
Cincinnati, Ohio, 45219
Mochida Investigative Site
Cincinnati, Ohio, 45242
Mochida Investigative Site
Cleveland, Ohio, 44195
Mochida Investigative Site
Coronado, California, 92118
Mochida Investigative Site
Detroit, Michigan, 48202
Mochida Investigative Site
Dothan, Alabama, 36305
Mochida Investigative Site
Durham, North Carolina, 27713
Mochida Investigative Site (2 sites)
Germantown, Tennessee, 38138
Mochida Investigative Site
Hialeah, Florida, 33016
Mochida Investigative Site
Houston, Texas, 77005
Mochida Investigative Site (2 sites)
Houston, Texas, 77030
Mochida Investigative Site
Jackson, Mississippi, 39202
Mochida Investigative Site
La Jolla, California, 92037
Mochida Investigative Site
Lexington, Kentucky, 40536
Mochida Investigative Site
Littleton, Colorado, 80120
Mochida Investigative Site
Los Angeles, California, 90048
Mochida Investigative Site
Nashville, Tennessee, 37211
Mochida Investigative Site
New Orleans, Louisiana, 70112
Mochida Investigative Site
Newport News, Virginia, 23602
Mochida Investigative Site
Plainview, New York, 11803
Mochida Investigative Site
Plymouth, Minnesota, 55446
Mochida Investigative Site
Providence, Rhode Island, 02903
Mochida Investigative Site
Richmond, Virginia, 23298
Mochida Investigative Site
San Antonio, Texas, 78234
Mochida Investigative Site
San Diego, California, 92123
Mochida Investigative Site
San Diego, California, 92161
Mochida Investigative Site
Seattle, Washington, 98101
Mochida Investigative Site
Tucson, Arizona, 85712
Mochida Investigative Site
Tupelo, Mississippi, 38801
About this study
Official title: A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).
Read the detailed description
This is a phase II, double-blinded, placebo-controlled study to investigate the safety, efficacy, and pharmacokinetic profile of two doses of EPA-E in adult subjects with NASH. Subjects are required to have a liver biopsy with proven NASH in the 6 month period prior to screening. Up to 70 subjects will be enrolled into each treatment arm in a 1:1:1 ratio, for a total of 210 subjects. Subjects will be stratified at randomization by presence or absence of diabetes. Duration of treatment is 12 months.
- Conditions
- Steatohepatitis
- Being tested
- Placebo capsule, EPA-E 300 mg capsule
- Keywords
- omega-3 fatty acids, alanine transaminase, triglycerides, lipids, EPA, ethyl-EPA, ethyl icosapentate, Non Alcoholic steatohepatitis, Non Alcoholic fatty liver disease, fatty acids
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo capsuleDrug
3x Placebo capsules three times a day (TID) for 365 days
EPA-E 300 mg capsuleDrug
2x 300 mg capsules + placebo capsule TID for 365 days
EPA-E 300 mg capsuleDrug
3x 300 mg capsules TID for 365 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 3x placebo capsules TID Receives: Drug: Placebo capsule |
| EPA-E 1800 mg/day | Experimental | 2x EPA-E 300 mg capsules + 1placebo capsule TID Receives: Drug: EPA-E 300 mg capsule |
| EPA-E 2700 mg/day | Experimental | 3x EPA-E 300 mg capsules TID Receives: Drug: EPA-E 300 mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies
Patient is considered a responder if histological examination shows:
Composite NAS of <=3 AND no worsening in Fibrosis OR Improvement in NAS by >=2 across at least 2 of the NAS components AND no worsening in fibrosis
A priori threshold for statistical significance is p<0.05, 1-sided
Measured: 12 months
Alanine Transaminase (ALT) Levels
Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;
- EPA-E 2700 mg and Placebo groups
- EPA-E 1800 mg and Placebo groups
Measured: 3 month endpoint
Alanine Transaminase (ALT) Levels
Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;
- EPA-E 2700 mg and Placebo groups
- EPA-E 1800 mg and Placebo groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154985
- Sponsor's protocol ID
- MCH-02-001
- Status last verified
- Oct 2014
- First submitted
- 29 Jun 2010
- Last updated
- 20 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sanyal AJ, Abdelmalek MF, Suzuki A, Cummings OW, Chojkier M; EPE-A Study Group. No significant effects of ethyl-eicosapentanoic acid on histologic features of nonalcoholic steatohepatitis in a phase 2 trial. Gastroenterology. 2014 Aug;147(2):377-84.e1. doi: 10.1053/j.gastro.2014.04.046. Epub 2014 May 9.
PubMed 24818764
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
- ClinicalTrials.gov ID
- NCT01154985
- Acronym / sponsor ID
- MCH-02-001
- Conditions
- Steatohepatitis
- Keywords
- omega-3 fatty acids, alanine transaminase, triglycerides, lipids, EPA, ethyl-EPA, ethyl icosapentate, Non Alcoholic steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).
Detailed description
This is a phase II, double-blinded, placebo-controlled study to investigate the safety, efficacy, and pharmacokinetic profile of two doses of EPA-E in adult subjects with NASH. Subjects are required to have a liver biopsy with proven NASH in the 6 month period prior to screening. Up to 70 subjects will be enrolled into each treatment arm in a 1:1:1 ratio, for a total of 210 subjects. Subjects will be stratified at randomization by presence or absence of diabetes. Duration of treatment is 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo capsule3x placebo capsules TID |
| EPA-E 1800 mg/day | Experimental | Drug: EPA-E 300 mg capsule2x EPA-E 300 mg capsules + 1placebo capsule TID |
| EPA-E 2700 mg/day | Experimental | Drug: EPA-E 300 mg capsule3x EPA-E 300 mg capsules TID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of definite NASH
- Patients with diabetes taking stable doses of anti-diabetic agents are eligible
- No significant concomitant medical illness
Key exclusion criteria (9 listed)
- Diagnosis of cirrhosis.
- Serum ALT > 300 U/L
- Use of drugs associated with steatohepatitis
- Use of the following anit-NASH agents:
- Use of non-stable doses of the following anti-NASH agents: HMGCoA reductase inhibitors (statins), fibrates, probucol, ezetimibe, ursodiol (UDCA), taurine, betaine, N-acetylcysteine, s-adenosylmethionine (SAM-E), milk thistle, anti-TNF therapies, or probiotics.
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 |
|---|---|---|
| Placebo capsule3x Placebo capsules three times a day (TID) for 365 days | Drug | Placebo |
| EPA-E 300 mg capsule2x 300 mg capsules + placebo capsule TID for 365 days | Drug | EPA-E 1800 mg/day |
| EPA-E 300 mg capsule3x 300 mg capsules TID for 365 days | Drug | EPA-E 2700 mg/day |
Primary outcome
Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies
Time frame: 12 months
Patient is considered a responder if histological examination shows: Composite NAS of <=3 AND no worsening in Fibrosis OR Improvement in NAS by >=2 across at least 2 of the NAS components AND no worsening in fibrosis A priori threshold for statistical significance is p<0.05, 1-sided
Alanine Transaminase (ALT) Levels
Time frame: 3 month endpoint
Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between; 1. EPA-E 2700 mg and Placebo groups 2. EPA-E 1800 mg and Placebo groups
Alanine Transaminase (ALT) Levels
Time frame: 6 months
Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between; 1. EPA-E 2700 mg and Placebo groups 2. EPA-E 1800 mg and Placebo groups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24818764Sanyal AJ, Abdelmalek MF, Suzuki A, Cummings OW, Chojkier M; EPE-A Study Group. No significant effects of ethyl-eicosapentanoic acid on histologic features of nonalcoholic steatohepatitis in a phase 2 trial. Gastroenterology. 2014 Aug;147(2):377-84.e1. doi: 10.1053/j.gastro.2014.04.046. Epub 2014 May 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EPA-E 300 mg capsule in people with Steatohepatitis, run by Mochida Pharmaceutical Company, Ltd. at 34 sites in 2 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 3 inclusion and 9 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01154985, which also lists 1 linked publication.
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 20 Nov 2014.