Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver (SPARe-1)

Sanofi

Status and phase

Terminated

Phase 3

Conditions

Liver Cirrhosis

Ascites

Treatments

Drug: Satavaptan

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00359437

EFC4493

EUDRACT: 2006-000132-27

LTS10036

Details and patient eligibility

About

Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites.

Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants 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).

Enrollment

501 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants with cirrhosis of the liver.
Participants 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 > 4 litres of fluid.
- at least one other therapeutic paracentesis in the previous 3 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.