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

Phase 3TerminatedNCT00359437

Sanofi501 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

501

Conditions

Ascites Liver Cirrhosis

Interventions

SatavaptanDRUG

oral administration once daily

placeboDRUG

oral administration once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

Sanofi-Aventis Administrative Office

Malvern, Pennsylvania, United States

Outcomes

Primary Outcomes

Number and time of recurrences of therapeutic paracenteses

Time frame: up to 12 weeks

Secondary Outcomes

Time from randomisation to first recurrence of ascites

Time frame: study period

Increase in ascites

Time frame: over 12 weeks

Data from ClinicalTrials.gov

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