Non-Alcoholic Fatty Liver DiseasePhase 4NCT00941642
Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
A Phase 4 study testing Lovaza in people with Non-Alcoholic Fatty Liver Disease, run by Huntington Medical Research Institutes at 1 site in United States.
Trial summary
Lovaza is the only fish oil supplement approved by the FDA. It is available by prescription for the treatment of hypertriglyceridemia (> 500 mg/dl). The primary mechanism appears to be a reduction in hepatic production of triglycerides. Also decreases the hepatic production of very low density lipoprotein (VLDL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Lovaza
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2012
- Phase
- Phase 4
- 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
- Over the age of 18
- Abnormal liver enzymes >40 IU/L. Definition of normal is ALT 19 for a woman and 30 for a man.
- Patients must meet ATP III criteria for metabolic syndrome: Central obesity as measured by waist circumference. Men - greater than or equal to 40 inches. Women - greater than or equal to 35 inches.
- Blood HDL cholesterol. Men - less than 40 mg/dL. Women - less than 50 mg /dL.
- Blood pressure greater than or equal to 130/85.
- Fasting glucose greater than or equal to 100 mg/dL but less than 126mg/dL on 2 separate occasions.
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- Fasting blood triglycerides greater than or equal to 150 mg/dL.
- Hepatitis B and C negative
- Autoimmune Hepatitis, Wilson's Disease, Hemochromatosis negative, etc.
- NASH or NAFLD on biopsy of any degree:
Who cannot join
- Below the age of 18.
- Other Causes of Liver inflammation.
- Daily alcohol consumption in excess of 20 grams / day for men and 10 grams / day for women. If participant unable to quantify his/her alcohol intake, they should be excluded.
- Taking a prescribed medication know to cause fatty liver disease 6 months prior to enrollment. Also, subjects with secondary causes of fatty liver disease (ie. Gastric bypass) should be excluded from the study.
- Cirrhosis.
- Subjects on oral insulin-sensitizing agents and other drugs currently being used in the treatment of NAFLD. Such agents include fibrates, Vitamin E, S-adenosyl-methionine, betaine, N-acetylcysteine, and milk thistle extracts.
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- Diabetes (fasting sugar above 126mg/dl).
- Pregnancy or lactation. Women of child bearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test prior to treatment and be practicing an acceptable form of barrier contraception for the duration of the study.
- Any serious or chronic disease that in the opinion of the Principal Investigator (PI), may affect the assessment of safety or efficacy parameters. This includes but is not limited to, patients with malignancy, other than Basal Cell Carcinomas.
- Patients who, in the opinion of the site PI, are not suitable candidates for enrollment or would not comply with the requirements of the study.
- Patients who have had a liver transplant.
- Any allergy to fish.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
HMRI - Liver Center
Pasadena, California, 91105
Roberta A Fitzgerald, RN, 626-397-5825, robertaf@hmri.org
Edward A Mena, MD
About this study
Lovaza is the only fish oil supplement approved by the FDA. It is available by prescription for the treatment of hypertriglyceridemia (> 500 mg/dl). The primary mechanism appears to be a reduction in hepatic production of triglycerides. Also decreases the hepatic production of very low density lipoprotein (VLDL). There also may be antioxidant properties as well. The thought behind using Lovaza as a treatment for non-alcoholic fatty liver disease (NAFLD) is two fold. It would help in the decrease production of triglycerides by the liver and have antioxidant properties decreasing the production of free radicals in the liver. In doing so, steatohepatitis, fibrosis, and perhaps cirrhosis and liver cancer would be prevented.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Lovaza, placebo control
- Keywords
- Nonalcoholic Fatty Liver Disease (NAFLD), Lovaza, Steatosis, Non-Alcoholic steatohepatitis (NASH)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovazaDrug
Approximately 50% of study subjects will be randomized to the active treatment arm -Lovaza. Subjects will be dosed with 4g of Lovaza gel capsules daily for a minimum of 48 weeks duration.
placebo controlDrug
Approximately 50% of study subjects will be randomized to the placebo arm of this study. Placebo arm subjects will receive 4g of placebo gel caps daily for a minimum of 48 weeks duration.
| Study group | Role | What they receive |
|---|---|---|
| Lovaza | Active comparator | Single blind, active treatment arm Lovaza, is the only fish oil supplement approved by the FDA. The Lovaza treatment group will take 4g of Lovaza daily for a minimum of 48 weeks. Receives: Drug: Lovaza |
| Placebo | Placebo comparator | Single blind, Placebo arm study drug will contain 994.0 mg of corn oil and 6mg of alpha tocopherol as an excipient in a soft gelatin capsule shell. Subjects will take 4g daily for a minimum of 48 weeks. Receives: Drug: placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if Lovaza improves fibrosis and the NASH activity index.
Measured: 48 weeks
Secondary outcomes (1)
To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huntington Medical Research Institutes
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Edward A Mena, MD, Principal investigator, Huntington Medical Research Institutes - Liver CenterMyron J Tong, PhD, MD., Study director, Huntington Medical Research Institutes - Liver Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941642
- Sponsor's protocol ID
- LOVAZA - NAFLD
- Other IDs
- IND # 105,085.
- Status last verified
- Jun 2010
- First submitted
- 15 Jul 2009
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT00941642
- Acronym / sponsor ID
- LOVAZA - NAFLD
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Nonalcoholic Fatty Liver Disease (NAFLD), Lovaza, Steatosis, Non-Alcoholic steatohepatitis (NASH)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huntington Medical Research InstitutesUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 17 Jul 2009 (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.
Lovaza is the only fish oil supplement approved by the FDA. It is available by prescription for the treatment of hypertriglyceridemia (> 500 mg/dl). The primary mechanism appears to be a reduction in hepatic production of triglycerides. Also decreases the hepatic production of very low density lipoprotein (VLDL). There also may be antioxidant properties as well. The thought behind using Lovaza as a treatment for non-alcoholic fatty liver disease (NAFLD) is two fold. It would help in the decrease production of triglycerides by the liver and have antioxidant properties decreasing the production of free radicals in the liver. In doing so, steatohepatitis, fibrosis, and perhaps cirrhosis and liver cancer would be prevented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lovaza | Active comparator | Drug: LovazaSingle blind, active treatment arm Lovaza, is the only fish oil supplement approved by the FDA. The Lovaza treatment group will take 4g of Lovaza daily for a minimum of 48 weeks. |
| Placebo | Placebo comparator | Drug: placebo controlSingle blind, Placebo arm study drug will contain 994.0 mg of corn oil and 6mg of alpha tocopherol as an excipient in a soft gelatin capsule shell. Subjects will take 4g daily for a minimum of 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Over the age of 18
- Abnormal liver enzymes >40 IU/L. Definition of normal is ALT 19 for a woman and 30 for a man.
- Patients must meet ATP III criteria for metabolic syndrome: Central obesity as measured by waist circumference. Men - greater than or equal to 40 inches. Women - greater than or equal to 35 inches.
- Blood HDL cholesterol. Men - less than 40 mg/dL. Women - less than 50 mg /dL.
- Blood pressure greater than or equal to 130/85.
Key exclusion criteria (12 listed)
- Below the age of 18.
- Other Causes of Liver inflammation.
- Daily alcohol consumption in excess of 20 grams / day for men and 10 grams / day for women. If participant unable to quantify his/her alcohol intake, they should be excluded.
- Taking a prescribed medication know to cause fatty liver disease 6 months prior to enrollment. Also, subjects with secondary causes of fatty liver disease (ie. Gastric bypass) should be excluded from the study.
- Cirrhosis.
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 |
|---|---|---|
| LovazaApproximately 50% of study subjects will be randomized to the active treatment arm -Lovaza. Subjects will be dosed with 4g of Lovaza gel capsules daily for a minimum of 48 weeks duration. | Drug | Lovaza |
| placebo controlApproximately 50% of study subjects will be randomized to the placebo arm of this study. Placebo arm subjects will receive 4g of placebo gel caps daily for a minimum of 48 weeks duration. | Drug | Placebo |
Primary outcome
To determine if Lovaza improves fibrosis and the NASH activity index.
Time frame: 48 weeks
1 secondary outcome
To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy.
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2010.
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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.
Edward A Mena, MD principal investigator
Huntington Medical Research Institutes - Liver Center
Myron J Tong, PhD, MD. study director
Huntington Medical Research Institutes - Liver Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lovaza in people with Non-Alcoholic Fatty Liver Disease, run by Huntington Medical Research Institutes at 1 site in United States.
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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta A Fitzgerald, RN (626.397.5825, robertaf@hmri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if Lovaza improves fibrosis and the NASH activity index. (time frame: 48 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 10 Jun 2010.