Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00941642
• Other study ID #: LOVAZA - NAFLD
• Secondary ID: IND # 105,085.
• Status: Recruiting
• Phase: Phase 4
• First received: July 15, 2009
• Last updated: June 9, 2010
• Start date: September 2009
• Est. completion date: September 2012

Study information

• Verified date: June 2010
• Source: Huntington Medical Research Institutes
• Contact: Roberta A Fitzgerald, RN
• Phone: 626.397.5825
• Email: robertaf[@]hmri.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• Lovaza
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 control
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.

Locations

Country	Name	City	State
United States	HMRI - Liver Center	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Huntington Medical Research Institutes	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if Lovaza improves fibrosis and the NASH activity index.		48 weeks	No
Secondary	To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy.		48 weeks	No