ArticleHepatology (Baltimore, Md.)2018
Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science.
Article in Hepatology (Baltimore, Md.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers, 4 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
69 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Berberine Effects in Pre-Fibrotic Stages of Non-Alcoholic Fatty Liver Disease-Clinical and Pre-Clinical Overview and Systematic Review of the Literature.International journal of molecular sciences · 2024Pooled it
- EASL-EASD-EASO Clinical Practice Guidelines on the Management of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).Obesity facts · 2024Guideline
- Glucagon-Like Peptide-1 Receptor Agonists for Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes: A Meta-Analysis.Frontiers in endocrinology · 2021Pooled it
- Sodium-Glucose Co-Transporter 2 Inhibitors for Non-Alcoholic Fatty Liver Disease in Asian Patients With Type 2 Diabetes: A Meta-Analysis.Frontiers in endocrinology · 2020Pooled it
- Impact of obeticholic acid on the lipoprotein profile in patients with non-alcoholic steatohepatitis.Journal of hepatology · 2020Trial
- Epidemiological and socio-economic burden of MASH (previously known as NASH) in Europe: a systematic literature review.Journal of endocrinological investigation · 2026Review
- Portal Vein Thrombosis in Cirrhotic Candidates for Liver Transplantation and Its Impact on the Transplant Accessibility.Journal of clinical medicine · 2026Article
- Polyunsaturated fatty acids as a potential preventive and therapeutic intervention for metabolic dysfunction-associated steatotic liver disease and its progression to hepatocellular carcinoma.Frontiers in nutrition · 2026Review
- [Current research progress status in identifying hepatocellular ballooning degeneration in nonalcoholic steatohepatitis].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025Review
- Genomic Exploration of Nonalcoholic Fatty Liver Disease: Insights From Gene Expression and Variation in Morbidly Obese Individuals.Journal of obesity · 2025Article
- TAT as a new marker and its use for noninvasive chemical biopsy in NASH diagnosis.Molecular medicine (Cambridge, Mass.) · 2024Article
- Acute-on-chronic liver failure in metabolic dysfunction-associated fatty liver disease patients: a disease multiplier.Hepatology international · 2024Review
- Twenty-five years of addressing cutting-edge scientific, policy, and regulatory issues through collaboration: The Forum for Collaborative Research.Clinical and translational science · 2024Article
- Fatty liver disease - non alcoholic to metabolic - A transition of concepts!!Journal of family medicine and primary care · 2024Review
- Sex-based Disparities in Liver Transplantation for Hepatocellular Carcinoma and the Impact of the Growing Burden of NASH.Transplantation direct · 2024Article
- A Novel Antioxidant, Hydrogen-Rich Coral Calcium Alters Gut Microbiome and Bile Acid Synthesis to Improve Methionine-and-Choline-Deficient Diet-Induced Non-Alcoholic Fatty Liver Disease.Antioxidants (Basel, Switzerland) · 2024Article
- Prevalence of metabolic syndrome among patients with hepatocellular carcinoma of different etiologies: a retrospective study.Infectious agents and cancer · 2024Article
- Nonalcoholic steatohepatitis: A comprehensive updated review of risk factors, symptoms, and treatment.Heliyon · 2024Review
- Endpoints in NASH Clinical Trials: Are We Blind in One Eye?Metabolites · 2024Review
- Towards precision medicine in non-alcoholic fatty liver disease.Reviews in endocrine & metabolic disorders · 2023Review
9 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
Abstract
Nonalcoholic steatohepatitis (NASH) is an important cause of liver-related morbidity and mortality. There are no approved therapies, and the results of clinical trials have been difficult to compare due to inconsistent definitions of relevant disease parameters in patients with NASH. The natural course of the disease has not been rigorously characterized, particularly with respect to the contributions of underlying obesity, type 2 diabetes, and other comorbidities and the treatments provided for these comorbidities. Efforts to perform analyses of pooled data are limited by heterogeneous case definitions used across studies to define disease states. There remains a major unmet need in the field to develop standardized definitions for populations for interventional trials. Such definitions are expected to impact how endpoints for clinical trials are constructed. The Liver Forum is a multistakeholder effort including US and European regulatory agencies, academic investigators, professional and patient representative organizations, and industry to catalyze therapeutic development for NASH by developing potential solutions to barriers to development. The Case Definitions Working Group was established by The Liver Forum to evaluate the validity of case definitions for populations to be included in clinical trials for NASH from a regulatory science perspective. Based on such analyses, specific recommendations are provided noting the strengths and weaknesses of the case definitions along with knowledge gaps that require additional study. (Hepatology 2018;67:2001-2012).
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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.