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

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ClinicalTrials.gov Identifier: NCT00941642
Recruitment Status : Unknown
Verified June 2010 by Huntington Medical Research Institutes.
Recruitment status was:  Recruiting
First Posted : July 17, 2009
Last Update Posted : June 10, 2010
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Huntington Medical Research Institutes

Tracking Information
First Submitted Date  ICMJE July 15, 2009
First Posted Date  ICMJE July 17, 2009
Last Update Posted Date June 10, 2010
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
To determine if Lovaza improves fibrosis and the NASH activity index. [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00941642 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy. [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
Official Title  ICMJE Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Non-Alcoholic Fatty Liver Disease
Intervention  ICMJE
  • 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.
  • 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.
Study Arms
  • 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.
    Intervention: Drug: Lovaza
  • 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.
    Intervention: Drug: placebo control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 16, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date September 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00941642
Other Study ID Numbers  ICMJE LOVAZA - NAFLD
IND # 105,085.
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Edward A. Mena, MD, Huntington Medical Research Institutes
Study Sponsor  ICMJE Huntington Medical Research Institutes
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
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
PRS Account Huntington Medical Research Institutes
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP