Clinical trial NCT00941642: Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
Official title: Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Nonalcoholic Fatty Liver Disease (NAFLD)
Lovaza
Steatosis
Non-Alcoholic steatohepatitis (NASH)
Lead sponsor: Huntington Medical Research Institutes
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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:

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: To determine if Lovaza improves fibrosis and the NASH activity index.
timeFrame: 48 weeks
Secondary outcomes:
measure: To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: HMRI - Liver Center
state: California
Study officials:
affiliation: Huntington Medical Research Institutes - Liver Center
name: Edward A Mena, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huntington Medical Research Institutes - Liver Center
name: Myron J Tong, PhD, MD.
role: STUDY_DIRECTOR
References: