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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Non-Alcoholic Fatty Liver Disease

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

48 weeks

Safety Issue:

No

Principal Investigator

Edward A Mena, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntington Medical Research Institutes - Liver Center

Authority:

United States: Food and Drug Administration

Study ID:

LOVAZA - NAFLD

NCT ID:

NCT00941642

Start Date:

September 2009

Completion Date:

September 2012

Related Keywords:

  • Non-Alcoholic Fatty Liver Disease
  • Nonalcoholic Fatty Liver Disease (NAFLD)
  • Lovaza
  • Steatosis
  • Non-Alcoholic steatohepatitis (NASH)
  • Fatty Liver
  • Liver Diseases

Name

Location

HMRI - Liver CenterPasadena, California  91105