NASH - Nonalcoholic Steatohepatitis
Phase 3 treatment trials
Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis
Condition & Intervention: Compensated Cirrhosis, NASH: Obeticholic Acid (oral)
PI: Bambha, Landis
Site: UWMC, HMC
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis
Condition & Intervention: Decompensated Cirrhosis: Emricasan (oral)
PI: Bambha, Landis
Site: UWMC, HMC
Title: AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis
Condition & Intervention: NASH: Cenicriviroc (oral)
PI: Bambha, Landis
Site: UWMC, HMC
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis
Condition & Intervention: NASH with Fibrosis: Elafibranor (oral)
PI: Landis
Site: HMC
Registry/observational Studies
Title: A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
Condition & Intervention:
NASH/NAFLD - Patient Registry
PI: Landis
Site: HMC
NASH/NAFLD 16HEP01
Title: Procurement of Blood Samples from Subjects with Diagnosed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) for Use in the Development of a Liver Fibrosis Test
Condition & Intervention: NASH - Fibrosis Stages (F0-F4)
PI: Landis
Site: HMC
Phase 2 treatment trials
Title: A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
Condition & Intervention:(NASH) NASH: EDP-305 (Oral)
PI: Landis
Site: HMC
Cirrhosis
Interventional Study
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A Randomized, Double-blind Placebo-controlled, Multi-Center Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C/3131) [Phase 3]
This research study aims to see if Rifaximin SSD-40IR (IND) given twice daily will help delay the first episode of overt hepatic encephalopathy (OHE) requiring hospitalization.
PI: Biggins
Site: UWMC
HCV - Hepatitis C Virus
Registry/observational Studies
Title: Hepatitis C Therapeutic Registry and Research Network - A Longitudional, Observational Study
Condition & Intervention: HCV - patients being treated with treatments containing telaprvir or boceprevir
PI: Landis
Site: HMC
Open-label treatment studies
Title: A Multicenter, Open-label Study of Harvoni ® (Sofosbuvir Ledipasvir Fixed Dose Combination) in Subjects Infected With Chronic Hepatitis C and Advanced Heart Failure or Lung Disease
Condition and Intervention: Hep C, Heart Failure, Chronic Pulmonary Disease, Interstitial Lung Disease: Harvoni/Sofosbuvir/Ledipasvir
PI: Landis
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Title: A Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects With Chronic Hepatitis C Previously Treated With an NS5A Inhibitor + Sofosbuvir Therapy
Condition & Intervention: Hepatits C, HCV: Glacaprevir/Pibrentasvir 300mg, Ribavirin 200mg, Sofosbuvir 400mg (oral)
PI: Landis
Site: HMC
PBC - Primary Biliary Cholangitis
Registry/observational Studies
Title: A 5-year Longitudinal Observational Study of Patients with Primary Biliary Cholangitis
Condition & Intervention: PBC - Patient Registry
PI: Landis
Site: HMC
Phase 2 treatment trials
Title: A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxy
Condition & Intervention: PBC: EDP-305 (oral)
PI: Landis
Site: HMC
PSC - Primary Sclerosing Cholangitis
Phase 2 treatment trial
Title: A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)
Condition & Intervention: PSC: HTD1801 (oral)
PI: Landis
Site: HMC
ALF - Acute Liver Failure
Observational study
A Mult-Center Group to Study Acute Liver Failure
Condition & Intervention: ALF/ALI
PI: Liou
Site: UWMC
HE - Hepatic Encephalopathy
Phase 2 treatment trial
Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
Condition & Intervention: OHE: Rifaximin and lactulose (oral)
PI: Biggins, Landis
Site: UWMC, HMC
HCC - Hepatocellular Carcinoma
Observational Study
Title: A 5-year Longitudinal Observational Study of the Natural History and Management of Patients With Hepatocellular Carcinoma (HCC)
Condition & Intervention:
Hepatocellular Cancer
PI: Landis
Site: HMC
Fatty Liver
Observational Study
DECT Liver Fat Quantification and Comparison with MR PDFF
This study aims to see if Dual-Energy CT (DECT), can accurately identify and quantify liver fat (hepatic steatosis). Our goal is to analyze image data acquired from routine DECT and determine the accuracy of liver fat quantification compared to the current clinical standard of MRI.
PI:Kolokythas/ Bambha
Site: UWMC
Additional topics
- HBV - Hepatitis B Virus
- HRS - Hepatorenal Syndrome
- NAFLD - Nonalcoholic Fatty Liver Disease
- AH - Alcoholic Hepatitis