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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Liver Cirrhosis; Ascites

Treatments: Drug: Satavaptan; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00358878

EFC4492

LTS10036

EudraCT : 2006-000132-27

Details and patient eligibility

About

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).

Enrollment: 463 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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463 participants in 2 patient groups, including a placebo group

Satavaptan

Experimental group

Treatment:

Drug: Satavaptan

Placebo

Placebo Comparator group

Treatment:

Drug: placebo