Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Satavaptan

Criteria

Inclusion Criteria:

• Participants with cirrhosis of the liver

• Participants with clinically evident ascites primarily managed by diet and/or diuretics

• Stable treatment of ascites for at least the previous 2 weeks without paracentesis

• Participants having undergone no more than one therapeutic paracentesis in the previous 6 months.

Exclusion Criteria:

• Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt

• Known hepatocellular carcinoma

• Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma

• Participants previously exposed to satavaptan in the past 12 months