Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Summary

Primary: 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).

Timeline

Start

2006-08

Primary completion

2008-12

Completion

2008-12

Outcome

Missed primary endpoint

Stopped: “Study was terminated due to safety reason.”

paper Satavaptan was not more effective than placebo in the control of ascites in any of the populations studied as estimated by the primary efficacy endpoints PMID 21836029 ↗

Publications

• Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Gines P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	satavaptan	Small molecule	5 mg	Oral
Subject	satavaptan	Small molecule	10 mg	Oral

Indications