Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT02923804
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2016-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients
Sponsor:
Pronova BioPharma
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients When Added to Standard of Care
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective, randomized, placebo-controlled, double-blind trial to determine the effect of high concentrate omega-3 capsules on the omega-3 status of patients with non-alcoholic fatty liver.
Detailed Description:
Subjects with non-alcoholic fatty liver (simple steatosis) confirmed within the last year by ultrasound or other imaging modality will be recruited to the study. Subjects will be randomized to a treatment arm of high concentrate capsules or placebo for a 6 month treatment period.Omega-3 content of red blood cells (omega-3 index) will be measured for primary endpoint assessment. Quantitative MRI will be performed to determine the effect on liver fat content.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: