The Palliative Performance Scale has been shown to predict survival among hospice and palliative medicine patients in the outpatient and inpatient clinical settings, where lower PPS scores are directly related to shorter survival. We seek to evaluate if this relationship persists among a racially diverse, older adult population when assessed at the time of admission from the emergency department.
The study will enroll well-compensated cirrhotic as well as non-cirrhotic Genotype 1 HCV infected subjects who are treatment experienced with Sovaldi (Sofosbuvir) and an NS5a Inhibitor (such as Harvoni). Subjects will be randomized to 12 or 16 weeks of treatment of G/P with or without Ribavirin.
This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy
The purpose of this study is to confirm the efficacy and safety of terlipressin in the treatment of adult subjects admitted to the hospital with hepatorenal syndrome (HRS) Type 1. Hepatorenal syndrome Type 1 is a severe, but potentially reversible, form of renal failure that afflicts patients with severe chronic liver disease associated with cirrhosis. This will be a randomized, placebo-controlled, and double-blinded multi-center study. Patients will be randomly be placed in either a terlipressin-treatment group or a placebo group. Neither you nor the study team will know which group you have been placed in. The study drug will be given as an IV injection every 6 hours while the patient is an inpatient at the hospital every 6 hours. This is a phase 3 study, with prior studies already showing promising results.
This is a treatment study for participants with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis to access whether the study drug emricasan compared to placebo improves event-free survival in subjects. Event free refers to subjects not experiencing any new compensation events and MELD score progression. The study treatment duration will be 48 weeks (1 year) with study visits every 4 weeks. Study drug will be provided at no cost to and participants will be compensated for their time and travel.
This is a phase 3, randomized, double-blind, placebo controlled study evaluating the safety and efficacy of an investigational drug called selonsertib in subjects with NASH and bridging (F3) fibrosis.
The primary goal of this study is to evaluate whether selonsertib (SEL) can cause fibrosis reversal and reduce progression to cirrhosis and associated complications in subjects with NASH and bridging (F3) fibrosis. The secondary goal of this study is to assess the safety and tolerability of SEL in subjects with NASH and bridging (F3) fibrosis. Subjects will be treated for 240 weeks, and participation in the study can last up to 260 weeks, which includes an 8-week screening period, a 240-week treatment period, and a 4-week follow-up period and a telephone follow-up at 12 weeks after the Week 240 Visit.
This is a Phase 3, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of a drug called selonsertib in subjects with compensated cirrhosis due to non-alcoholic steatohepatitis (NASH). The primary goal of this study is to evaluate whether selonsertib (SEL) can reverse the liver fibrosis seen in patients with NASH cirrhosis and reduce the potential complications associated with cirrhosis. A secondary goal of this study is to assess the safety and tolerability of the drug, selonsertib, in subjects with NASH cirrhosis. Participation in this study can last up to 260 weeks, which includes an 8-week screening period, a 240-week treatment period, and a 4-week follow-up period, and a telephone follow-up visit 12 weeks after the week 240 visit.
TARGET-HCC is a 5-year, longitudinal, observational study of the natural history and management of patients with HCC. The study will address important clinical questions that remain unanswered in the management of HCC with a unique research registry of participants with HCC from academic and community real-world practices. TARGET-HCC is disease focused, not drug specific, which allows for continuous acquisition of real-world evidence regarding the natural history, management, and outcomes of treatment with current therapies and new treatments that may be utilized in usual clinical practice.
This is a 5-year, longitudinal, observational study of patients with NAFL or NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
This is a treatment study for people who have Nonalcoholic Steatohepatitis (NASH) fibrosis but not cirrhosis. The purpose of the study is to see whether the oral investigational medication, Volixibat potassium, is effective and safe in treating liver fibrosis.
This study will be a Phase 2, 48-week, multicenter, double-blind, randomized, PBO-controlled, parallel group,
proof of concept, dose-finding study, with one IA after at least 80 subjects have received 24 weeks of treatment.
There will be 3 active arms of volixibat (5, 10 and 20 mg) and a PBO arm. Subjects will be randomized to
receive one of three doses of volixibat (5, 10, or 20 mg) once daily (QD) or PBO in a 1:1:1:1 ratio. Subjects
with fibrosis stages F0 through F3 may be enrolled, but the number of F0 subjects will be capped at 88 if 1 dose
is dropped after the IA and at 78 if 2 doses are dropped (approximately 30% of the total number of subjects).
Depending on the outcome of the IA, one or more treatment arms will be discontinued or the study may be
terminated. The follow-up period will be 4 weeks after last dose. Subjects will be expected to visit the study
center at least 10 times.