Page last updated: 2024-10-26
eicosapentaenoic acid ethyl ester and Cirrhosis, Liver
eicosapentaenoic acid ethyl ester has been researched along with Cirrhosis, Liver in 1 studies
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 Cirrhosis, Liver