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

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lovaza
placebo control
Sponsored by
Huntington Medical Research Institutes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Nonalcoholic Fatty Liver Disease (NAFLD), Lovaza, Steatosis, Non-Alcoholic steatohepatitis (NASH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HMRI - Liver CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lovaza

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

To determine if Lovaza improves fibrosis and the NASH activity index.

Secondary Outcome Measures

To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy.

Full Information

First Posted
July 15, 2009
Last Updated
June 9, 2010
Sponsor
Huntington Medical Research Institutes
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00941642
Brief Title
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

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Huntington Medical Research Institutes
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
Nonalcoholic Fatty Liver Disease (NAFLD), Lovaza, Steatosis, Non-Alcoholic steatohepatitis (NASH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lovaza
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lovaza
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo control
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine if Lovaza improves fibrosis and the NASH activity index.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta A Fitzgerald, RN
Phone
626.397.5825
Email
robertaf@hmri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward A Mena, MD
Organizational Affiliation
Huntington Medical Research Institutes - Liver Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myron J Tong, PhD, MD.
Organizational Affiliation
Huntington Medical Research Institutes - Liver Center
Official's Role
Study Director
Facility Information:
Facility Name
HMRI - Liver Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta A Fitzgerald, RN
Phone
626-397-5825
Email
robertaf@hmri.org
First Name & Middle Initial & Last Name & Degree
Edward A Mena, MD
First Name & Middle Initial & Last Name & Degree
Myron J Tong, PhD, MD.

12. IPD Sharing Statement

Learn more about this trial

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

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