Hugo E. Vargas, M.D.

The purpose of this study is to evaluate the outcome of hospitalization related to the presence of cirrhosis. We are participating in optional blood, saliva, urine, ascitic fluid and stool collection. 

This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months.

The purpose of this study is to determine the current practice and outcomes in the following areas of hospitalized cirrhotic subjects: Community-acquired infections: determinants and outcomes, Nosocomial infections: determinants and outcomes, Development of second infections, Factors predicting ICU care, organ failure, death and disability, Patterns and adequacy of albumin use in infected and non-infected subjects, Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia and hypernatremia, Peri and post-liver transplant outcomes, regiional variations in outcomes and therapeutic strategies, and compare the ICU and 30 day course of patients with cirrhosis who get admitted to the ICU to those without cirrhosis in the ICU.

The purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90, in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score ≥ 32 and MELD scores 21-30, inclusive.

The aim of this study is to evaluate the association of resting measured energy expenditure (mREE), VO2, VCO2, and respiratory quotient (RQ) with clinical and metabolic outcomes in the setting of liver transplantation.

The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.

The purpose of this study is designed to evaluate the effectiveness and safety of intravenous Lucassin® (terlipressin) versus a placebo for the treatment of type 1 hepatorenal syndrome in patients receiving standard of care albumin therapy.

The primary objective of this program is to provide Daclatasvir (DCV) for 24 weeks to be given in combination with Sofosbuvir (SOF) to post-liver transplant subjects with chronic hepatitis C recurrence and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to < 12 months, including advanced fibrosis or fibrosing cholestatic hepatitis.This protocol will be opened at specific clinical sites for the treatment of individual subjects for whom there are no other treatment options and will allow for the collection of safety and efficacy data.

The purpose of this multicenter, double-blind, randomized, placebo-controlled study is 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.

The purpose of this study is to measure the rates of continuing viral presence, following anti-viral therapy with combined Peg-Interferon and Ribavirin in patients that have had a liver transplant, are immune suppressed with Neoral or tacrolimus, and have a recurring infection with the Hepatitis C virus.

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 purpose of this study is to evaluate the safety and effectiveness of OCE-205 at various doses.

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 determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/GS-5816 FDC for 24 weeks in adults with hepatitis C virus (HCV) infection and Child-Pugh (CPT) class B cirrhosis.

This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated interferon and RBV. The primary study hypothesis is that in at least one of the study arms, the percentage of participants achieving sustained viral response 12 weeks after the end of all study treatment (SVR12) will be superior to 58%.

The purpose of this study is to evaluate the safety, tolerability and effect on liver histologic parameters with administration of the investigational product, ARO-AAT, in participants with alpha-1 antitrypsin deficiency (AATD). Participants will receive multiple subcutaneous doses of ARO-AAT.

The purpose of this study is to evaluate the safety and effectiveness of zetomipzomib in addition to standard-of-care in patients with autoimmune hepatitis (AIH) who have failed standard-of-care treatment, had an incomplete biochemical response to ≥3 months of standard-ofcare treatment, or had a disease flare after standard-of-care treatment.

The purpose of this study is to evaluate the safety and effectiveness, as determined by 90-day incidence of mortality or transplant, for intravenous (IV) DUR-928 (30 mg or 90 mg) in subjects with severe alcohol-associated hepatitis, also known as severe alcoholic hepatitis, (AH) with pre-treatment Maddrey Discriminant Function (MDF) score ≥ 32 and MELD scores 21-30. Additionally, to evaluate the effectiveness, as determined by 90-day mortality and 28-day mortality with or without transplant for IV DUR-928 (30 mg or 90 mg) in subjects with severe AH.

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Subjects will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

The purpose of this study is to compare the safety and effectiveness of using ABT-493/ABT-530, to the combination of sofosbuvir and daclatasvir in treating adults with genotype 3 chronic hepatitis C virus infection.

The purpose of this study is to evaluate the safety and efficacy of ABT-493 and ABT-530 (or ABT-493/ABT-530) coadministered with and without ribavirin in adults with chronic HCV genotypes 2, 3, 4, 5 or 6 infection. In part 4, the primary objectives also include to assess the efficacy (SVR12) of treatment with ABT-493/ABT-530 combination regimen in GT2-infected DAA-naive subjects without cirrhosis compared to historical SVR12 rate of treatment with sofosbuvir plus RBV in GT2-infected DAA-naive subjects without cirrhosis.

A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.

 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 primary purpose of this study is to collect and analze data evaluating the effectiveness of the alfapump to control ascites as determined by the reduction in the need for repeated paracentesis compared to baseline

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24 week regimen of ombitasvir/ABT-450/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30, including those on hemodialysis.

Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients who are severely affected present with subacute onset of fever, hepatomegaly, leukocytosis, marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). However, milder forms of alcoholic hepatitis often do not cause any symptoms. Alcoholic hepatitis usually persists and progresses to cirrhosis if heavy alcohol use continues. If alcohol use ceases, alcoholic hepatitis resolves slowly over weeks to months, sometimes without permanent sequelae but often with residual cirrhosis. F-652 is a recombinant fusion protein containing human interleukin 22 (IL-22) and human Immunoglobulin G2 (IgG2)-Fc produced in CHO cells in serum-free culture. F-652 under development is intended to treat patients with graft vs host disease (GvHD) after bone marrow transplantation, and acute alcoholic hepatitis (AAH), a severe form of alcoholic liver disease (ALD). Both GvHD and AAH are diseases with unmet medical need. The current investigational new drug (IND) application is to conduct a phase Ia clinical study in GvHD patients to evaluate the safety and pharmacokinetic profile, and biomarkers of F-652 treatment by intravenous infusion (IV). IL-22 is a member of the IL-10 family of cytokines which control bacterial infection, homeostasis, and tissue repair. IL-22 may be used to treat patients with ALD because of its antioxidant, anti-apoptotic, anti-steatotic, anti-microbial, and proliferative effect that have been demonstrated in various experimental systems.

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis.

The purpose of this study is to evaluate the outcome of hospitalization related to the presence of cirrhosis. We are participating in optional blood, saliva, urine, ascitic fluid and stool collection. 

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 primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.

The purpose of this study is to find out how the survival rate of patients with cirrhosis can be improved when admitted to the hospital with complications such as infections.

The purpose of this study is to define the determinants of cirrhosis progression using clinical and specialized biomarkers over time in North America through a prospective outpatient registry.

The puropose of this study is to utilize a discrete-choice experiment (DCE) survey to elicit benefit-risk preferences for interventional treatment attributes in patients with refractory or recurrent ascites due to liver cirrhosis.

The overall objective of the patient preference evaluation is to understand how patients tradeoff the benefits and risks of the alfapump related to the primary endpoints of the current POSEIDON clinical trial in support of future marketing application.

The alfapump system is designed to reduce or eliminate the need for therapeutic paracentesis and to provide relief from symptoms of tense ascites with its attendant effects on patient quality of life (QOL) and nutrition. fits and risks of the alfapump related to the primary endpoints of the current POSEIDON clinical trial in support of future marketing application.

This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population will consist of subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.

The purpose of this study is to define the prevalence and impact of cognitive impairment and their impact on HRQOL in elderly patients with cirrhosis compared to elderly patients without cirrhosis.