Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis

Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science

(2018) Mohammad Shadab Siddiqui et al.   HEPATOLOGY

A randomized, placebo-controlled trial of cenicriviroc for treatment of nonalcoholic steatohepatitis with fibrosis

(2018) Scott L. Friedman et al.   HEPATOLOGY

Baseline Parameters in Clinical Trials for Nonalcoholic Steatohepatitis: Recommendations From the Liver Forum

(2017) Yuval A. Patel et al.   GASTROENTEROLOGY

Drug-induced Liver Injury

(2017) David E. Kleiner   GASTROENTEROLOGY CLINICS OF NORTH AMERICA

The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases

(2017) Naga Chalasani et al.   HEPATOLOGY

Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention

(2017) Zobair Younossi et al.   Nature Reviews Gastroenterology & Hepatology

Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) in HIV

(2017) Jürgen Kurt Rockstroh   Current HIV/AIDS Reports

Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design

(2016) Scott Friedman et al.   Contemporary Clinical Trials

Drug-Induced Liver Injury in Patients With Preexisting Chronic Liver Disease in Drug Development: How to Identify and Manage?

(2016) Naga Chalasani et al.   GASTROENTEROLOGY

Elafibranor, an Agonist of the Peroxisome Proliferator−Activated Receptor−α and −δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening

(2016) Vlad Ratziu et al.   GASTROENTEROLOGY

Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes

(2016) Zobair M. Younossi et al.   HEPATOLOGY

EASL–EASD–EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease

(2016)   JOURNAL OF HEPATOLOGY

Acute-on-chronic liver failure in cirrhosis

(2016) Vicente Arroyo et al.   Nature Reviews Disease Primers

Risk of Acute Liver Failure in Patients With Drug-Induced Liver Injury: Evaluation of Hy’s Law and a New Prognostic Model

(2015) Vincent Lo Re et al.   Clinical Gastroenterology and Hepatology

Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis

(2015) Eduardo Vilar-Gomez et al.   GASTROENTEROLOGY

Nonalcoholic Steatohepatitis Is the Second Leading Etiology of Liver Disease Among Adults Awaiting Liver Transplantation in the United States

(2015) Robert J. Wong et al.   GASTROENTEROLOGY

Features and Outcomes of 899 Patients With Drug-Induced Liver Injury: The DILIN Prospective Study

(2015) Naga Chalasani et al.   GASTROENTEROLOGY

Screening diabetic patients for non-alcoholic fatty liver disease with controlled attenuation parameter and liver stiffness measurements: a prospective cohort study

(2015) Raymond Kwok et al.   GUT

Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: Findings and recommendations from an American Association for the Study of Liver Diseases-U.S. Food and Drug Administration Joint Workshop

(2015) Arun J. Sanyal et al.   HEPATOLOGY

Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies: Implications for prognosis and clinical management

(2015) Stuart McPherson et al.   JOURNAL OF HEPATOLOGY

Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): a multicentre, randomised, placebo-controlled trial

(2015) Brent A Neuschwander-Tetri et al.   LANCET

Relationship Between Changes in Serum Levels of Keratin 18 and Changes in Liver Histology in Children and Adults With Nonalcoholic Fatty Liver Disease

(2014) Raj Vuppalanchi et al.   Clinical Gastroenterology and Hepatology

Liver Safety Assessment: Required Data Elements and Best Practices for Data Collection and Standardization in Clinical Trials

(2014) Mark I. Avigan et al.   DRUG SAFETY

Evolution of the Food and Drug Administration Approach to Liver Safety Assessment for New Drugs: Current Status and Challenges

(2014) John R. Senior   DRUG SAFETY

Causality Assessment for Suspected DILI During Clinical Phases of Drug Development

(2014) Arie Regev et al.   DRUG SAFETY

Liver Safety Assessment in Special Populations (Hepatitis B, C, and Oncology Trials)

(2014) Gerd A. Kullak-Ublick et al.   DRUG SAFETY

Use of Hy's Law and a New Composite Algorithm to Predict Acute Liver Failure in Patients With Drug-Induced Liver Injury

(2014) Mercedes Robles–Diaz et al.   GASTROENTEROLOGY

Idiosyncratic Drug-Induced Liver Injury Is Associated With Substantial Morbidity and Mortality Within 6 Months From Onset

(2014) Robert J. Fontana et al.   GASTROENTEROLOGY

Effects of purified eicosapentaenoic and docosahexaenoic acids in nonalcoholic fatty liver disease: Results from the WELCOME* study

(2014) Eleonora Scorletti et al.   HEPATOLOGY

An assessment by the Statin Liver Safety Task Force: 2014 update

(2014) Harold Bays et al.   Journal of Clinical Lipidology

Reliability of causality assessment for drug, herbal and dietary supplement hepatotoxicity in the Drug-Induced Liver Injury Network (DILIN)

(2014) Paul H. Hayashi et al.   LIVER INTERNATIONAL

Inhibition of 11β-HSD1 with RO5093151 for non-alcoholic fatty liver disease: a multicentre, randomised, double-blind, placebo-controlled trial

(2014) Norbert Stefan et al.   Lancet Diabetes & Endocrinology

Vitamin E and changes in serum alanine aminotransferase levels in patients with non-alcoholic steatohepatitis

(2013) J. H. Hoofnagle et al.   ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Diabetes type II, other medical conditions and pancreatic cancer risk: a prospective study in The Netherlands

(2013) P Eijgenraam et al.   BRITISH JOURNAL OF CANCER

Drug-Induced Steatohepatitis

(2013) Vaishali Patel et al.   Clinics in Liver Disease

Simple Noninvasive Systems Predict Long-term Outcomes of Patients With Nonalcoholic Fatty Liver Disease

(2013) Paul Angulo et al.   GASTROENTEROLOGY

Efficacy and Safety of the Farnesoid X Receptor Agonist Obeticholic Acid in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

(2013) Sunder Mudaliar et al.   GASTROENTEROLOGY

Hepatic histological findings in suspected drug-induced liver injury: Systematic evaluation and clinical associations

(2013) David E. Kleiner et al.   HEPATOLOGY

A population-based study on the prevalence of NASH using scores validated against liver histology

(2013) Jenni Hyysalo et al.   JOURNAL OF HEPATOLOGY

Limited value of plasma cytokeratin-18 as a biomarker for NASH and fibrosis in patients with non-alcoholic fatty liver disease

(2013) Kenneth Cusi et al.   JOURNAL OF HEPATOLOGY

Liraglutide efficacy and action in non-alcoholic steatohepatitis (LEAN): study protocol for a phase II multicentre, double-blinded, randomised, controlled trial

(2013) Matthew J Armstrong et al.   BMJ Open

γ-Glutamyl transferase

(2012) Diana Zaineff Banderas et al.   EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY

Acute-on chronic liver failure

(2012) Rajiv Jalan et al.   JOURNAL OF HEPATOLOGY

A pre-marketing ALT signal predicts post-marketing liver safety

(2012) Cynthia A. Moylan et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Case Definition and Phenotype Standardization in Drug-Induced Liver Injury

(2011) G P Aithal et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Serum ferritin is an independent predictor of histologic severity and advanced fibrosis in patients with nonalcoholic fatty liver disease

(2011) Kris V. Kowdley et al.   HEPATOLOGY

A phase 2, randomized, double-blind, placebo-controlled study of GS-9450 in subjects with nonalcoholic steatohepatitis

(2011) Vlad Ratziu et al.   HEPATOLOGY

Endpoints and clinical trial design for nonalcoholic steatohepatitis

(2011) Arun J. Sanyal et al.   HEPATOLOGY

Clinical significance of serum autoantibodies in patients with NAFLD: results from the nonalcoholic steatohepatitis clinical research network

(2011) Raj Vuppalanchi et al.   Hepatology International

Effect of Vitamin E or Metformin for Treatment of Nonalcoholic Fatty Liver Disease in Children and Adolescents

(2011) Joel E. Lavine   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

A Maxed-Out Liver: A Case of Acute-On-Chronic Liver Failure

(2011) Gene Im et al.   SEMINARS IN LIVER DISEASE

Risk Factors for Idiosyncratic Drug-Induced Liver Injury

(2010) Naga Chalasani et al.   GASTROENTEROLOGY

Safety and efficacy of long-term statin treatment for cardiovascular events in patients with coronary heart disease and abnormal liver tests in the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) Study: a post-hoc analysis

(2010) Vasilios G Athyros et al.   LANCET

Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis

(2010) Arun J. Sanyal et al.   NEW ENGLAND JOURNAL OF MEDICINE

HFE Genotype, Parenchymal Iron Accumulation, and Liver Fibrosis in Patients With Nonalcoholic Fatty Liver Disease

(2009) Luca Valenti et al.   GASTROENTEROLOGY

Variability in the upper limit of normal for serum alanine aminotransferase levels: A statewide study

(2009) Anand Dutta et al.   HEPATOLOGY

Using controlled clinical trials to learn more about acute drug-induced liver injury

(2008) Paul B. Watkins et al.   HEPATOLOGY