Doug A. Simonetto, M.D.

The purpose of this study is to establish the Maximum Tolerated Dose (MTD), assess the safety, tolerability, and pharmacokinetics of subcutaneous PHIN-214 in participants with compensated and decompensated cirrhosis. In addition, various exploratory markers of effectiveness will be analyzed. 

The purpose of this study is to assess dose-related safety, early efficacy, pharmacokinetics and pharmacodynamics of INT-787 in patients with severe alcohol-associated hepatitis (sAH).

 The purpose of this study is to evaluate the safety and effectiveness of R2R01 combined with terlipressin as compared to terlipressin alone in the treatment of patients with Hepatorenal Syndrome - Acute Kidney Injury (HRS-AKI).

The purpose of this study is to assess the effectiveness, safety, and tolerability of the combination of zibotentan and dapagliflozin, and dapagliflozin monotherapy versus placebo in participants with cirrhosis with features of portal hypertension.

The purpose of this study is to evaluate the application of machine learning models, DULCE and ACE scores, in the identification of advanced liver fibrosis (stage 3-4) and clinically significant portal hypertension, respectivelly

The objectives of this study are to determine if the DULCE score can accurately predict advanced liver fibrosis (stage 3-4) using 6-lead and 12-lead ECGs, to assess the performance of ACE score for detection of Clinically Significant Portal Hypertension, using 6-lead and 12-lead ECG, and to assess and validate the performance of DULCE and ACE scores in 6-lead ECGs compared to 12-lead ECGs.

The purpose of this study is to identify the clinical characteristics, the management and the outcomes of acute kidney injury (AKI) in patients with cirrhosis worldwide. Additionally, to establish the severity of AKI across different regions, to identify precipitants of AKI across different centers, to identify the phenotypes of AKI across different centers, to evaluate differences in the management of AKI across different centers and their impact on clinical outcomes, and to assess outcomes of acute kidney injury (resolution of AKI, in-hospital mortality, 28-day mortality, 90-day mortality).

The purpose of this study is to define a comprehensive digital phenotype through radio signal-enabled passive environment monitoring, associated with clinical outcomes in patients with cirrhosis.

The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve patient and provider satisfaction.
 

The purpose of this study is to evaluate safety and effectiveness of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.

The purspoe of this study is to determine whether a smartphone-enabled application with stool imaging technology allows patients with decompensated cirrhosis and hepatic encephalopathy on lactulose, to achieve and maintain the recommended number of daily BMs and Bristol stool type more often than they would otherwise, thereby helping them more effectively prevent HE and reduce healthcare utilization.

early detection of hepatic encephalopathy

The purpose of this study is to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, and accumulation of fluid in the abdominal cavity (ascites).

The overall objectives of this study are to determine the effectiveness of ACE 2.0 model in early detection of advanced liver fibrosis, and to determine the acceptance and barriers for use of an AI-enabled algorithm for prediction of liver disease in primary care.

The purpose of this study is to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, and accumulation of fluid in the abdominal cavity (ascites).

The purpose of this study is to assess safety/effectiveness for continuous terlipressin infusion adult subjects on the liver transplant wait list with Hepatorenal syndrome- Acute Kidney Injury (HRS-AKI).

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new decompensation events, and MELD score progression are events) in subjects with decompensated NASH cirrhosis.

This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.

The purpose of this study is to confirm the effectiveness and safety of  terlipressin in the treatment of adult patients with hepatorenal syndrome (HRS) type 1.

The study aims are to evaluate the safety and effectiveness of OCE-205 at various doses. Participants will receive treatment by intravenous infusion and will continue this treatment until participants meet primary endpoint or any discontinuation criteria.  OCE-205 is being tested to treat participants who have developed Hepatorenal Syndrome-Acute Kidney Injury as a complication of cirrhosis with ascites.

The purpose of this study is to evaluate the clinical effectiveness of BIV201 continuous infusion in addition to SOC compared to SOC alone in adult patients with refractory ascites secondary to decompensated hepatic cirrhosis.

The purpose of this study is to evaluate the safety of acamprosate in individuals with alcohol-use disorder (AUD) and alcohol-related liver disease.

The primary purpose of this study is to is to develop an advanced multiparametric liver magnetic resonance elastography (MRE) imaging technology for early identification of hepatocellular carcinoma (HCC) involvement, differentiation, and risks of microvascular invasion.

The purpose of this study is to develop an advanced multiparametric liver magnetic resonance elastography (MRE) imaging technology for monitoring hepatic inflammation during direct acting antiviral (DAA) treatment, evaluation risks of severe liver injury, and HCC development.

The primary purpose of this study is to develop an understanding of the prevalence, characteristics, and outcomes of major bleeding and clinically relevant non-maor bleeding in hospitalized patients with cirrhosis undergoing invasive procedures.

The purpose of this study is to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects.

The purpose of this study is to determine if a mobile application used to label stools according to the Bristol Stool Scale can safely assist subjects with lactulose titration and lead to decreased rates of hepatic encephalopathy. Additionally, to assess patient willingness to interact with mobile application in taking pictures of bowel movements.

The purpose of this study is to identify exomic alterations that contribute to the development of liver disease.