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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Huntington Medical Research Institutes.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Huntington Medical Research Institutes
ClinicalTrials.gov Identifier:
NCT00941642
First received: July 15, 2009
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Non-Alcoholic Fatty Liver Disease
Drug: Lovaza
Drug: placebo control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Huntington Medical Research Institutes:

Primary Outcome Measures:
  • To determine if Lovaza improves fibrosis and the NASH activity index. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lovaza
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.
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 Comparator: Placebo
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.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941642

Contacts
Contact: Roberta A Fitzgerald, RN 626.397.5825 robertaf@hmri.org

Locations
United States, California
HMRI - Liver Center Recruiting
Pasadena, California, United States, 91105
Contact: Roberta A Fitzgerald, RN    626-397-5825    robertaf@hmri.org   
Principal Investigator: Edward A Mena, MD         
Sub-Investigator: Myron J Tong, PhD, MD.         
Sponsors and Collaborators
Huntington Medical Research Institutes
GlaxoSmithKline
Investigators
Principal Investigator: Edward A Mena, MD Huntington Medical Research Institutes - Liver Center
Study Director: Myron J Tong, PhD, MD. Huntington Medical Research Institutes - Liver Center
  More Information

No publications provided

Responsible Party: Edward A. Mena, MD, Huntington Medical Research Institutes
ClinicalTrials.gov Identifier: NCT00941642     History of Changes
Other Study ID Numbers: LOVAZA - NAFLD, IND # 105,085.
Study First Received: July 15, 2009
Last Updated: June 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Huntington Medical Research Institutes:
Nonalcoholic Fatty Liver Disease (NAFLD)
Lovaza
Steatosis
Non-Alcoholic steatohepatitis (NASH)

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 30, 2014