Clinical Trials

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.

This Registry will enroll cirrhotic participants with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.

This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with patients having cramps due to their cirrhotic liver disease.

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 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 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.

The purpose of this study is to determine whether the ORBERA Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.

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

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 purpose of this study is to evaluate improvements in predictive accuracy for risk of decompensation over time for a composite risk score that includes non-modifiable and modifiable clinical, pathophysiological and behavioral risk factors (i.e., a “test” model) compared to a composite risk score that includes clinical risk factors alone (i.e., a “base” model) in a large, multi-center cohort of patients with cirrhosis.

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

The purpose of this study is to assess the effectiveness and safety of rifaximin SSD-40IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites. Participants who have cirrhosis determined by histopathological evidence, transient elastography or presence of esophageal varices, and who have not previously experienced OHE, spontaneous bacterial peritonitis (SBP), esophageal variceal bleeding (EVB), or acute kidney injury-hepatorenal syndrome (AKI-HRS) will be enrolled in the study. 

early detection of hepatic encephalopathy

The purpose of this study is to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.

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. 

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.

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.

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 evaluate the diagnostic performance of Endoscopic Ultrasound (EUS) shear wave elastography in the assessment of liver fibrosis compared to magnetic resonance (MR) elastography.

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.

The purpose of this registry is to enroll patients who have cirrhosis with a sustained viral response after receiving a sofosbuvir-based treatment without interferon, either while participating in a Gilead-sponsored hepatitis C virus study or commercially at selected sites. Once enrolled, the patients will be followed for up to 5 years.

Primary sclerosing cholangitis is a chronic inflammation of the bile ducts of unknown cause and eventually results in cirrhosis of the liver. These patients are at increased risk for the development of cancer rising from bile duct tissue. Chromosomal abnormalities of the bile duct tissue, particularly trisomy 7 (i.e. three copies of chromosome 7) can be detected in biopsy samples. Erlotinib (Tarceva) is a human EGFR type 1 tyrosine kinase inhibitor and offers greater survival benefit to EGFR positive patients. This study will assist in determining the safety and tolerability of Tarceva in patients who have primary sclerosing cholangitis.

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 study plans to follow three groups of cirrhotic patients from the time of hospital dismissal randomly divided into either receiving standard of care, using devices through which they can communicate with the clinical teams and using devices and structured follow-up over thirty days. The study aims to develop these devices so as to learn quickly about issues that patients and their caregivers are facing so that clinicans can intervene to stop unnecessary re-hospitalizations in this population.

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.

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 primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.

The purpose of this study is to determine agreement between cardiopulmonary exercise testing and cardiac stress testing (SOC) for the identification of subclinical coronary artery disease in liver transplant candidates, to determine agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (SOC) for the identification of cirrhotic cardiomyopathy in liver transplant candidates, and to determine agreement between peak oxygen consumption from cardiopulmonary exercise testing and the liver frailty index or the six-minute walk test (SOC), for the identification of frailty in liver transplant candidates.

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

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 primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

The primary objectives of this study are: - To assess the safety and tolerability of selonsertib (SEL), GS-0976, and GS-9674, administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to Nonalcoholic Steatohepatitis (NASH) - To evaluate changes in liver fibrosis, without worsening of NASH

Primary biliary cirrhosis is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The purpose of this study is to assess the effect of obeticholic acid compared to a placebo, both combined with stable standard care, on the clinical outcomes of patients with primary biliary cirrhosis. 

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 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.

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 develop and validate a brief patient reported outcomes questionaire that is responsive to ascites-related symptoms in liver cirrhosis.

The primary objective of this study is to evaluate whether the combination of semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR) causes fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with compensated cirrhosis due to NASH.

The purpose of this study is to evaluate the usefulness of new markers found in blood that might help to diagnose of liver cancer (HCC) early among people with cirrhosis. We hope that this study will show that these new markers could identify HCC at an earlier stage where better treatment options are available.

The purpose of this study is to validate an NMR-based (Nuclear magnetic resonance) serum metabolite constellation for detection of early Hepatocellular carcinoma (HCC) lesions in liver cirrhosis.

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.

This study is to evaluate the safety and efficacy of simtuzumab (GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases:

• Randomized Double-Blind Phase
• Open Label Phase (optional)

This study will evaluate whether simtuzumab (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with non-alcoholic steatohepatitis (NASH). It will consist of 2 phases: - Randomized Double-Blind Phase - Open Label Phase (optional)

The goals of this study are to establish the role of circulating nucleic acid based biomarkers in early diagnosis, prognosis or treatment response in human diseases. These studies will determine whether alterations in circulating nucleic acids can distinguish between healthy and cancer tissue. 

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 evaluate the effectiveness of 2 mg/kg and 4 mg/kg lean body mass (LBM) of belapectin (GR-MD-02) compared to placebo in preventing the development of esophageal varices.

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.

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 purose of this study is to assess the effectiveness, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.

A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information ...

We purpose of this study is to evaluate the diagnosis accuracy of the Controlled Attenuation Parameter (CAP) measured by FibroScan® (both with M and XL probes) in all patients who are undergoing liver biopsy for any liver disease.