Research & Clinical Trials

• Drug-Induced Liver Injury Network (DILIN): A multi-Center Longitudinal Study of Drug and CAM-Induced Liver Injury : (Prospective and Acute)
• Drug-Induced Liver Injury Network (DILIN) Idiosyncratic Liver Injury Associated with Drugs (ILIAD): A Retrospective Study

Link to DILIN website: http://www.dilin.org/

• Integrating Patient Reported Outcomes Assessment in Advanced Liver Disease using PROMIS (Patient Reported Outcomes Measurement Information System)
• Introducing Behavioral Health into the Treatment of Chronic Liver Disease (CLD): An Integrated Hybrid Model
• Remote Monitoring of Symptoms and Cognitive Function Using Telehealth: T-Liver Project (Tobacco Grant)

• Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis (Intercept)
• A Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Efficacy of IDN-6556-12 in Subjects with NASH (Conatus)
• A randomized, double-blind, placebo controlled, 2- part, adaptive design, multicenter 12-week study to assess safety, tolerability and efficacy of LJN452 in patients with NASH (Novartis)
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with NASH and fibrosis (GenFit)

• A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected subjects Who Have Failed Prior Treatment With Sofosbuvir-based Therapies (Gilead Sciences, Inc).
• A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in Subjects with Chronic HCV GT1 or GT3 Infection who have Failed a Direct Acting Antiviral Regimen (Merck).
• A Long Term Follow-Up Study to Evaluate the Durability or Virologic Response and/or viral Resistance Patterns of Subjects with Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial (Merck)
• Clinical Evaluation of Xpert HCV VL Assay (Cepheid)
• A Multi-Center, Prospective Evaluation of the Beckman Coulter DxN HCV Viral Load Assay as an Aid in the Management of HCV-Infected Individuals Undergoing Antiviral Therapy (Beckman Coulter, Inc)
• Collection of Blood Specimens from Subjects Infected with Chronic Hepatitis C (Genotypes 2 and 3) and Treated with Sofosbuvir plus Ribavirin (Roche Molecular Systems, Inc)

• A Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects with Alcohol-Induced Liver Decompensation (AILD) (Vital Therapies).
• VTL-308, A Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects with Alcohol-Induced Liver Decompensation (AILD) (Vital Therapies).
• TREAT002 trial: A Double-Blind, Placebo-Controlled Trial of Obeticholic Acid in Patients with moderately severe Alcoholic Hepatitis (NIAAA/ Indiana University)

• A multi-center, randomized, placebo-controlled, double-blind study to confirm efficacy and safety of Terlipressin in subjects with Hepatorenal Syndrome Type 1 (The confirm study)

• Collection of Plasma Samples From Individuals Initiating Therapy with Entecavir or Tenofovir for Chronic Hepatitis B Virus Infection for the Clinical Evaluation of the Aptima (Hologic Incorporation (subaward with Duke)
• Multicenter, Prospective Evaluation of the Beckman Coulter DxN HBV Assay as an Aid in the Management of HBV-infected Individuals Undergoing Antiviral Therapy