This Phase 2b study is a randomized, double-blind, parallel-arm, placebo-controlled trial to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg compared with placebo in subjects with NASH. Subjects will be randomized 1:1:1 to receive Saroglitazar Magnesium 4 mg, Saroglitazar Magnesium 2 mg, or placebo via IVRS/IWRS. Total duration of the study will be up to 89 weeks including two screening visits (12 weeks), randomization and double-blind treatment phase (76 weeks), and a safety follow-up of 1 week after the last administration of study drug. Subjects will be evaluated at the study site for 14 scheduled visits. During the course of the study subjects will have 2 liver biopsies and 6 transient elastography/FibroScan performed to monitor liver fibrosis.
The purpose of this research study is to evaluate the efficacy of BIV201 continuous infusion with SOC compared to SOC alone in adult patients with refractory ascites secondary to decompensated hepatic cirrhosis.
Cirrhotic patients with refractory ascites have a very poor prognosis and suffer from complications due to the continuous buildup of ascites fluid in their abdomens. There are currently no approved pharmacological treatments for refractory ascites and first-line standard of care is limited to repeated mechanical removal by paracentesis, with liver transplantation the only definitive treatment. The vasoconstrictor terlipressin, which is not yet approved in the United States, reduces splanchnic vasodilation associated with portal hypertension in cirrhotics and can lead to a decrease in ascites.
This exploratory dose-titration trial is designed to evaluate the therapeutic efficacy of BIV201 continuous infusion on ascites recurrence and clinical complications of decompensated cirrhosis with refractory ascites, and to explore the hypothesis that if ascites recurrence or accumulation is reduced during the intervention period, consisting of two 28-day treatment periods separated by a wash-out
interval, there will be a better clinical outcome (reduction in complications) long-term over 180 days than in those treated with SOC alone
This is a prospective cohort study of subjects with portal hypertension to examine whether increased sphingosine 1 phosphate : ceramide ratio and circulating bile acids are associated with HPS in patients with advanced liver disease. The study will consist of 400 individuals who are evaluated for liver transplantation at the Field Centers. This population has advanced liver disease and will represent the population with cirrhosis at the Centers. As is considered standard of clinical care for these patients and required for liver transplant evaluation, patients will undergo phlebotomy, interviews, pulmonary function testing, echocardiography, and arterial blood gas sampling at their initial evaluation. During the clinical phlebotomy, additional samples will be drawn for research purposes. If any of these procedures does not occur during the clinical visit, it may be conducted for research purposes. Six minute walk testing, frailty scales, SF36, and optional actigraphy, all of which are research-only assessments, will be performed at baseline. Subjects will then be followed via phone for the duration of the study period.