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).

An Expanded Access Phase 2 Study of Sofosbuvir with Ribavirin and with or without Pegylated Interferon for 24 weeks in Subjects who have undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C infection

This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.

Trial Website: https://clinicaltrials.gov/show/NCT01779518

A Phase 2 open-label study in patients with recurrent Genotype 1 hepAtitis C post orthotopic Liver transplAnt to eXplore the safety and efficacY of simeprevir and sofosbuvir with and without ribavirin

The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic liver transplant participants with recurrent hepatitis (inflammation of the liver) C virus (HCV) Genotype 1 infection.

Trial Website: https://clinicaltrials.gov/show/NCT02165189

A Study to Evaluate Chronic Hepatitis C Infection in Adult Liver Transplant Recipients

Clinical Study Protocol M12-999: Open-label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adult Liver Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection

This is a study to evaluate chronic Hepatitis C Virus infection.

Trial Website: https://clinicaltrials.gov/show/NCT01782495

A single center, open-label, randomized, controlled pilot trial to evaluate the efficacy and safety of everolimus conversion versus standard immunosuppression in liver transplant recipients

The purpose of this study is to evaluate the efficacy of an everolimus conversion (EVR) protocol as compared to the standard tacrolimus (TAC) based protocol in liver transplant recipients, as determined by renal function, rejection rates, and progression to fibrosis (in HCV positive subjects). Additionally, safety profile and tolerability of these regimens will be assessed.

Trial Website: https://clinicaltrials.gov/show/NCT01998789

A Phase II Randomized Multicenter Placebo- Controlled Blinded Study of Sorafenib Adjuvant Therapy in High Risk Orthotopic Liver Transplant (OLT) Recipients with Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine if sorafenib (sorafenib tosylate) is a safe and effective treatment option for preventing liver cancer in high risk patients following liver transplantation. Liver transplantation is a treatment option for liver cancer patients, but despite transplantation, the liver cancer can recur in the new, transplanted liver. It is not known whether sorafenib is effective in preventing cancer recurrence in high risk patients following liver transplantation.

Prospective Randomized Double Blind Placebo Controlled Trial of Rifaximin 550mg PO Twice Daily for Three Months to Prevent Recurrent Fibrosis in Liver Transplant Recipients with Chronic Hepatitis C Virus Infection

The purpose of this study is to determine if the administration of a poorly-absorbable antibiotic (rifaximin) for the first three months after liver transplant will reduce the amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that comes from the bacteria in intestines and may cause scarring in the liver.

Approximately 60 subjects will participate in this study. Subjects will be part of the study for approximately 1 year post transplant.