Clinical Trials

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 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.

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 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 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 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 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 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).