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
|Condition or disease||Intervention/treatment||Phase|
|Non-Alcoholic Fatty Liver Disease||Drug: Lovaza Drug: placebo control||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||September 2012|
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.
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.
- To determine if Lovaza improves fibrosis and the NASH activity index. [ Time Frame: 48 weeks ]
- To determine if Lovaza improves AST/ALT level and improves steatosis on biopsy. [ Time Frame: 48 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941642
|Contact: Roberta A Fitzgerald, RNfirstname.lastname@example.org|
|United States, California|
|HMRI - Liver Center||Recruiting|
|Pasadena, California, United States, 91105|
|Contact: Roberta A Fitzgerald, RN 626-397-5825 email@example.com|
|Principal Investigator: Edward A Mena, MD|
|Sub-Investigator: Myron J Tong, PhD, MD.|
|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|