Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver (SPARe-2)

Sanofi

Status and phase

Terminated

Phase 3

Conditions

Liver Cirrhosis

Ascites

Treatments

Drug: placebo

Drug: Satavaptan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00366795

LTS10036

EudraCT : 2006-000132-27

EFC6682

Details and patient eligibility

About

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).

Enrollment

241 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.