A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications in Subjects With Early Decompensated Liver Cirrhosis

The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis.

Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin.

Elizabeth C. Verna, MD

Sex Hormone Measurement and Measures of Frailty in the Setting of End Stage Liver Disease and Liver Transplantation: A Single Center Pilot Study

To assess the utility of frailty tools in predicting pre- and post-liver transplant morbidity and mortality in patients listed for liver transplant.

A 24 month, randomized, controlled, study to evaluate the efficacy and safety of concentration-controlled everolimus plus reduced tacrolimus compared to standard tacrolimus in recipients of living donor liver transplants

The purpose of this trial is to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.

Trial Website: https://clinicaltrials.gov/show/NCT01888432

Jean C. Emond, MD

A2ALL-Patients Safety System Improvements in Living Donor Liver Transplant

Living donor liver transplantation (LDLT), involves complex systems and processes of care that are particularly vulnerable to medical errors and preventable complications. This ancillary study of the Adult-to-Adult Living Liver Transplantation Cohort Study (A2ALL) will focus on conducting a proactive, systematic, and comprehensive assessment of the vulnerabilities in the systems and process of LDLT care to reduce medical errors and preventable complications thereby improving the safety of LDLT care.

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Transplant

The purpose of this study is to evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Participants will be randomized to receive 12 or 24 weeks of dosing with the LDV/SOF FDC tablet+ribavirin (RBV).

Trial Website: https://clinicaltrials.gov/show/NCT01938430

Expanded-access single named patient guidance document for the use of BMS 790052 in combination with sofosbuvir for the treatment of a patient with recurrent hepatitis C virus infection

The purpose of this program is to provide access to daclatasvir to patients who are infected with chronic hepatitis C virus (HCV).

A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

Trial Website: https://clinicaltrials.gov/show/NCT01457755

A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.

Trial Website: https://clinicaltrials.gov/show/NCT01457768

Relative Abundance and Spatial Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease

To establish the structure, abundance and localization of lipids and proteins within human liver biopsies and to better understand how they pertaining to Nonalcoholic Steatohepatitis (NASH).

Julia J Wattacheril, MD, MPH

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 (STOP-HE)

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

Trial Website: https://clinicaltrials.gov/show/NCT01966419

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