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

Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00366795

Acronym

SPARe-2

Enrollment

241

Registered

2006-08-21

Start date

2006-08-31

Completion date

2008-12-31

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites, Liver Cirrhosis

Brief summary

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).

Interventions

DRUGSatavaptan

oral administration once daily

DRUGplacebo

oral administration once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Number and time of recurrences of therapeutic paracenteses	up to 12 weeks

Secondary

Measure	Time frame
Time from randomisation to first recurrence of ascites	study period
Increase in ascites	over 12 weeks

Countries

Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Czechia, France, Germany, Malaysia, Mexico, Poland, Romania, Russia, Serbia, Singapore, Spain, Turkey (Türkiye), United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026