Page last updated: 2024-10-26
eicosapentaenoic acid ethyl ester and Liver Cirrhosis
eicosapentaenoic acid ethyl ester has been researched along with Liver Cirrhosis in 1 studies
Liver Cirrhosis: Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules.
Research Excerpts
| Excerpt | Relevance | Reference |
|---|
| "The primary efficacy end point was NAFLD activity score ≤ 3, without worsening of fibrosis; or a decrease in NAFLD activity score by ≥ 2 with contribution from >1 parameter, without worsening of fibrosis, 1 year after the last dose of EPA-E or placebo was given." | 2.79 | No significant effects of ethyl-eicosapentanoic acid on histologic features of nonalcoholic steatohepatitis in a phase 2 trial. ( Abdelmalek, MF; Chojkier, M; Cummings, OW; Sanyal, AJ; Suzuki, A, 2014) |
Research
Studies (1)
| Timeframe | Studies, this research(%) | All Research% |
|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 1 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
Authors
| Authors | Studies |
|---|
| Sanyal, AJ | 1 |
| Abdelmalek, MF | 1 |
| Suzuki, A | 1 |
| Cummings, OW | 1 |
| Chojkier, M | 1 |
Clinical Trials (1)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH[NCT01154985] | Phase 2 | 243 participants (Actual) | Interventional | 2010-06-30 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Alanine Transaminase (ALT) Levels
"Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups" (NCT01154985)
Timeframe: 3 month endpoint
| Intervention | U/L (Least Squares Mean) |
|---|
| Placebo | -19.3 |
| EPA-E 1800 mg/Day | -3.0 |
| EPA-E 2700 mg/Day | 2.8 |
Alanine Transaminase (ALT) Levels
"Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups" (NCT01154985)
Timeframe: 6 months
| Intervention | U/L (Mean) |
|---|
| Placebo | -19.1 |
| EPA-E 1800 mg/Day | -9.5 |
| EPA-E 2700 mg/Day | -3.0 |
Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies
"Patient is considered a responder if histological examination shows:~Composite NAS of <=3 AND no worsening in Fibrosis OR Improvement in NAS by >=2 across at least 2 of the NAS components AND no worsening in fibrosis~A priori threshold for statistical significance is p<0.05, 1-sided" (NCT01154985)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|
| Placebo | 18 |
| EPA-E 1800 mg/Day | 18 |
| EPA-E 2700 mg/Day | 20 |
Trials
1 trial available for eicosapentaenoic acid ethyl ester and Liver Cirrhosis