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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Ascites, Liver Cirrhosis

In brief

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).

Key facts

Study ID

NCT00366795

Run by

Sanofi

People needed

241

Starts

2006-08-01

Expected to finish

2008-12-01

Last updated by the study team

2016-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with cirrhosis of the liver.
• Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator.
• Patients with recurrent ascites having undergone both of the following:
• therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of = or > 4 litres of fluid.
• at least one other therapeutic paracentesis in the previous 3 months.

You may not qualify if…

• Patients with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.
• Known hepatocellular carcinoma.
• Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
• Patients previously exposed to satavaptan in the past 12 months.

Where it is running

• Sanofi-Aventis Administrative Office — Malvern, Pennsylvania, United States
• Sanofi-Aventis Administrative Office — San Isidro, Argentina
• Sanofi-Aventis Administrative Office — Macquarie Park, Australia
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — Sarajevo, Bosnia and Herzegovina
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Sofia, Bulgaria
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Kuala Lumpur, Malaysia
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — Bucharest, Romania
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Belgrade, Serbia
• Sanofi-Aventis Administrative Office — Singapore, Singapore
• Sanofi-Aventis Administrative Office — Barcelona, Spain
• Sanofi-Aventis Administrative Office — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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