Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of...
AscitesLiver CirrhosisPrimary: To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites. Secondary: To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).
An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention...
Malignant AscitesThe purpose of this study is to assess in a controlled prospective setting, the safety of the use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant ascites.
Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian...
Refractory Ovarian Cancer With Recurrent Symptomatic Malignant AscitesThe purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after intravenous (IV) infusion (IV+IP) (Double-Route Arm), and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for each Arm separately, in subjects with refractory ovarian cancer and recurrent malignant ascites. In both Arms, the plasma pharmacokinetics (PK) of BAX69 will be characterized, and pharmacodynamics (PD) markers will be explored in plasma and ascites. Two expansion cohorts will further assess the tolerability of the RP2D and explore clinical signs of efficacy.
Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment...
Liver CirrhosisMulticentre, open, randomised, and controlled trial conducted in patients diagnosed with recurrent/refractory ascites who meet inclusion/exclusion criteria. The efficacy of the Alfapump, TIPS and paracentesis with regard to the treatment of ascites will be compared. All patients will receive medical care for cirrhosis and ascites according to the institution's standards of care. Standard of care may include, but is not limited to the administration of diuretics, paracentesis and consideration for orthotopic liver transplantation.
Trial of Sunitinib for Refractory Malignant Ascites
AscitesThe study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.
Empagliflozin as a Novel Therapy in Refractory Ascites
Ascites HepaticThe aim of the present study is to investigate the safety, efficacy and cost-effectiveness of empagliflozin, a sodium glucose transporter 2 inhibitor, as an add on therapy to the standard care for refractory ascites in patients with liver cirrhosis
Safety and Tolerance Study of Recombinant Human Albumin Injection in Healthy Subjects.
AscitesA phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation study, and a positive-controlled multiple dose extension study to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy subjects
Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
AscitesLiver CirrhosisThe primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites. This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo~CAT). The first extension is followed by another long-term study (PASCCAL-1).
Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance...
AscitesTo investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance. Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.
Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic...
Cirrhotic AscitesM0002, an orally active, selective non-peptidergic antagonist of the vasopressin V2 receptor inhibits vasopressin-induced water reabsorption from the kidney. Therefore the aquaretic effect of M0002 has a potential clinical benefit in the treatment of ascites and hyponatreamia in cirrhotic patients.