Clinical Research
Our commitment to finding new, cutting edge therapies is reflected in our extensive involvement in multiple clinical trials.
Our research program has some of the highest patient recruitment rates anywhere in the country. For our patients, this means additional treatment options and access to new cutting edge therapies. Participation in clinical trials can also mean significant financial savings to our patients.
NASH Clinical Trials
GS-US-454-4378: A Phase 2, Randomized, Double-Blind, Placebo- Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: No
Intercept 747-304: 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
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: No
Prometheus 16HEP01: 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
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Yes
SHP626-201: A Phase 2 Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability and Efficacy of Volixibat Potassium, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi) in Adults with Nonalcoholic Steatohepatitis (NASH)
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Yes
IDN 6556-17: A Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Yes
IDN 6556-14: A Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Closed
GFT505-315-1: 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
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Yes
INTERCEPT REGENERATE 747-303: 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
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: No
GS-US-384-1943: A Phase 3, Randomized, Double-Blind, Placebo- Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Closed
GS-US-384-1944: A Phase 3, Randomized, Double-Blind, Placebo- Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Closed
IDN 6556-12: A Multicenter, Randomized, Double-Blind, Placebo- controlled Trial of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: No
Hepatitis C-Unresected
BGB-A317-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 versus Sorafenib as First- Line Treatment in Patients with Unresectable Hepatocellular Carcinoma
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: No
Hepatitis C (HCC)
AbbVie M16-135: A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: yes
AbbVie M14-222: An Open-Label, Multicenter Study to Evaluate Long- term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II)
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Closed
REFINE: Regorafenib observational study in hepatocellular carcinoma
Liver Failure
RSX-201: A Phase 2a, Multicenter, Double-Blinded, Randomized, Comparator- Controlled Noninferiority Trial to Compare the Efficacy and Safety of Spray- Dried Solvent/Detergent-Treated Plasma (Resusix®) with Fresh Frozen Plasma (FFP) in Patients with Acquired Coagulopathy due to Confirmed or Suspected Hepatic Disease for the Treatment of Active Bleeding or Prophylaxis of Surgical Bleeding
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: No
Hepatorenal Syndrome
CONFIRM MNK 19013058: A Multi-Center, Randomized, Placebo- Controlled, Double-Blind Study To Confirm Efficacy And Safety Of Terlipressin In Subjects With Hepatorenal Syndrome Type 1
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Yes
Acute Alcohol Hepatitis
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)
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Closed
GS-US-416-2124: A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination with Prednisolone versus Prednisolone Alone in Subjects with Severe Alcoholic Hepatitis (AH)
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Closed
Primary Biliary Cholangitis
SARO.16.004.03- PBC: A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis (EPICS)
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Enrolling
Other Trials
VTI 209: Protocol for Tracking Economic Data of Subjects Participating in All Vital Therapies, Inc. Sponsored ELAD® Protocols in the United States
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: Closed
ICA Survey Study: Epidemiology And Clinical Impact Of Bacterial Infections In Hospitalized Patients With Liver Cirrhosis: A Multicenter Observational Prospective Survey Among The Members Of The International Club Of Ascites
Principle Investigator: Nikolaos Pyrsopoulos, MD, PhD, MBA, FACP, AGAF, FAASLD, FRCP
Enrolling: No
For more information on our clinical trials, please contact:
Michelle Anyanwu, Study Coordinator Supervisor msa202 @njms.rutgers.edu
Melissa Saint-Natus, Study Coordinator saintnme@njms.rutgers.edu Kareen Moore, Research Assistant km1285@njms.rutgers.edu Hector Salcedo, Research Assistant hrs60@njms.rutgers.edu
For more information please visit https://clinicaltrials.gov/