NASH Trials

NASH - Nonalcholic Steatohepatitis

PHASE 3 TREATMENT TRIALS

NASH 747-304
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

NASH IDN-6556-17
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

NASH 747-303
Title: A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
Condition & Intervention: NASH: Obeticholic Acid (oral)
PI: Bambha, Landis
Site: UWMC, HMC

NASH 3152-301-002
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

NASH GFT505-315-1
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/OBSERVATION STUDIES

NASH  /NAFLD TARGET-NASH 
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

NASH EDP 305-101
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