Research & Clinical Trials

Liver Transplant

Title: A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin (HCIG) in Orthotopic Liver Transplant Recipients (Biotest study)
Principal Investigator: James Spivey, MD

Title: International Randomized Trial to Evaluate the Effectiveness of the Portable Organ Care System (OCS™) Liver for Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial).
Principal Investigator: Joseph Magliocca, MD

Pre Liver Transplant/Liver Disease

Title: A Phase 2a Study to Evaluate the Safety and Tolerability of OCR-002 (ornithine phenylacetate) in the Treatment of Patients with Acute Liver Failure/Severe Acute Liver Injury (STOP-ALF)
Principal Investigator: Ram Subramanian, MD

Title: Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenylacetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemia with an Episode of Hepatic Encephalopathy (Ocera STOP-HE Study)
Principal Investigator: Ram Subramanian, MD

Title: A Multi-Center Group to Study Acute Liver Failure
Principal Investigator: Ram Subramanian, MD

Title: Observational, Post-marketing Renal Safety Surveillance Registry in Subjects with Chronic Hepatitis B (HBV) Infection with Decompensated Liver Disease Receiving Nucleotide/side Therapy
Principal Investigator: James Spivey, MD

Title: A Phase 3b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis. Protocol 747-302
Principal Investigator: Ryan Ford, MD

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. REGENERATE study. Protocol 747-303
Principal Investigator: Ryan Ford, MD

Title: A Randomized, Double-Blind, Exploratory Phase 2 Study to Assess the Effects of ARI–3037MO on Hepatic Fat Metabolism in Patients with Dysglycemia and Evidence of Hepatic Steatosis with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis. Protocol: ARI-3037MO-006
Principal Investigator: Ram Subramanian, MD

Title: A Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD® in Subjects with Alcohol-Induced Liver Decompensation (AILD). VTL-308
Principal Investigator: Ram Subramanian, MD

Title: 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. Protocol GS-US-337-1746
Principal Investigator: Anjana Pillai, MD

Title: Health Literacy Amongst Liver Transplant Candidates
Principal Investigator: Joel Wedd, MD

Emory Transplant Center