Trial reportLiver international : official journal of the International Association for the Study of the Liver2019
Relationship between three commonly used non-invasive fibrosis biomarkers and improvement in fibrosis stage in patients with non-alcoholic steatohepatitis.
Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.
- Prognostic accuracy of FIB-4, NAFLD fibrosis score and APRI for NAFLD-related events: A systematic review.Liver international : official journal of the International Association for the Study of the Liver · 2021Pooled it
- Trial
- Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial.Nature medicine · 2021Trial
- Benefits of prolonged-release pirfenidone plus standard of care treatment in patients with advanced liver fibrosis: PROMETEO study.Hepatology international · 2020Trial
- Evaluation of the Short-term Effect of Pemafibrate on Liver Fibrosis Biomarkers Stratified by FIB-4 Index in Patients with Type 2 Diabetes Mellitus and Hypertriglyceridemia.Internal medicine (Tokyo, Japan) · 2026Article
- Testosterone Replacement Therapy Can Improve a Biomarker of Liver Fibrosis in Hypogonadal Men: A Subanalysis of a Prospective Randomized Controlled Study in Japan (EARTH Study).The world journal of men's health · 2025Article
- A Novel GLP-1 and FGF21 Fusion Protein for the Treatment of Non-alcoholic Steatohepatitis (NASH).Advanced pharmaceutical bulletin · 2025Article
- Role of noninvasive tests in the prognostication of metabolic dysfunction-associated steatotic liver disease.Clinical and molecular hepatology · 2025Review
- Serial Liver Stiffness Measurement and Fibrosis-4 Scores in Metabolic Dysfunction-Associated Steatotic Liver Disease.Digestive diseases and sciences · 2024Article
- Non-Invasive Serum Markers of Non-Alcoholic Fatty Liver Disease Fibrosis: Potential Tools for Detecting Patients with Cardiovascular Disease.Reviews in cardiovascular medicine · 2024Review
- Endoscopic Bariatric and Metabolic Therapies for Liver Disease: Mechanisms, Benefits, and Associated Risks.Journal of clinical and translational hepatology · 2022Review
- Effect of bariatric surgery on fatty liver disease in obese patients: A prospective one year follow-up study.Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia · 2022Article
- Noninvasive assessment of fibrosis among patients with nonalcoholic fatty liver disease [NAFLD].Metabolism open · 2022Article
- Relationship of ELF and PIIINP With Liver Histology and Response to Vitamin E or Pioglitazone in the PIVENS Trial.Hepatology communications · 2021Article
- Effects of antidiabetic agents on steatosis and fibrosis biomarkers in type 2 diabetes: A real-world data analysis.Liver international : official journal of the International Association for the Study of the Liver · 2021Article
- FIB-4 First in the Diagnostic Algorithm of Metabolic-Dysfunction-Associated Fatty Liver Disease in the Era of the Global Metabodemic.Life (Basel, Switzerland) · 2021Review
- The Appropriate Opportunity for Evaluating Liver Fibrosis by Using the FIB-4 Index in Patients with Nonalcoholic Fatty Liver Disease in Japan.Diagnostics (Basel, Switzerland) · 2020Article
- Advances in non-invasive biomarkers for the diagnosis and monitoring of non-alcoholic fatty liver disease.Metabolism: clinical and experimental · 2020Review
- Review
- Clinical Utility of an Increase in Magnetic Resonance Elastography in Predicting Fibrosis Progression in Nonalcoholic Fatty Liver Disease.Hepatology (Baltimore, Md.) · 2020Article
Corrections and comments
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Authors and funding
12 authors at 9 institutions in 1 country.
Funding
Abstract
BACKGROUND &
aimsNon-invasive biomarkers are needed for monitoring changes in liver histology in patients with non-alcoholic steatohepatitis (NASH). Obeticholic acid (OCA) was shown to improve fibrosis in patients with NASH in the FLINT trial; a post hoc analysis of these data was performed to determine the relationship between 3 non-invasive fibrosis markers and liver fibrosis improvement.
methodsIn the Phase 2b FLINT trial, patients were randomised (1:1) to receive 25 mg OCA or placebo once daily for 72 weeks. Aspartate aminotransferase:platelet ratio index (APRI), fibrosis-4 (FIB-4) index and non-alcoholic fatty liver disease fibrosis score (NFS) were evaluated in serum at baseline and weeks 24, 48, 72 and 96. Liver biopsies were obtained at baseline and 72 weeks.
resultsIn patients with fibrosis improvement at week 24, scores were reduced by a median of 34% for APRI, 10% for FIB-4 and 4% for NFS. Reductions in APRI (P = 0.015) and FIB-4 (P = 0.036), but not NFS (P = 0.201) at week 24, significantly correlated with ≥1-stage improvement in histologic fibrosis at week 72. Reductions in APRI at week 72 were significantly correlated with fibrosis improvement at week 72 (P = 0.012). Patients receiving OCA had significant reductions in all markers compared with patients receiving placebo at week 72 [APRI and FIB-4 (P < 0.0001); NFS (P < 0.05)].
conclusionsReadily available non-invasive markers may predict improvement in liver fibrosis in patients with NASH. Upon external confirmation and further refinement in larger populations, these markers may serve as surrogate endpoints in NASH clinical trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.