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

Liver Cirrhosis Clinical Trial

— SPARe-1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00359437
• Other study ID #: EFC4493
• Secondary ID: EUDRACT: 2006-00
• Status: Terminated
• Phase: Phase 3
• First received: August 1, 2006
• Last updated: July 17, 2009
• Start date: July 2006
• Est. completion date: October 2008

Study information

• Verified date: July 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 501
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with cirrhosis of the liver.

• 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 > 4 litres of fluid.

• at least one other therapeutic paracentesis in the previous 3 months.

Exclusion Criteria:

• Patients with an existing functional TIPS (transjugular intrahepatic portosystemic shunt) 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Liver Cirrhosis

Intervention

Drug:
• satavaptan (SR121463B)
oral administration once daily
• placebo
oral administration once daily

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	San Isidro
Australia	Sanofi-Aventis Administrative Office	Macquarie Park
Belgium	Sanofi-Aventis Administrative Office	Diegem
Bosnia and Herzegovina	Sanofi-Aventis Administrative Office	Sarajevo
Bulgaria	Sanofi-Aventis Administrative Office	Sofia
Canada	Sanofi-Aventis Administrative Office	Laval
Croatia	Sanofi-Aventis Administrative Office	Zagreb
Czech Republic	Sanofi-Aventis Administrative Office	Praha
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Hungary	Sanofi-Aventis Administrative Office	Budapest
Israel	Sanofi-Aventis Administrative Office	Natanya
Italy	Sanofi-Aventis Administrative Office	Milano
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul
Malaysia	Sanofi-Aventis Administrative Office	Kuala Lumpur
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Serbia	Sanofi-Aventis Administrative Office	Belgrade
Singapore	Sanofi-Aventis Administrative Office	Singapore
South Africa	Sanofi-Aventis Administrative Office	Midrand
Spain	Sanofi-Aventis Administrative Office	Barcelona
Taiwan	Sanofi-Aventis Administrative Office	Taipei
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey
United States	Sanofi-Aventis Administrative Office	Malvern	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Czech Republic,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Portugal,  Romania,  Serbia,  Singapore,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and time of recurrences of therapeutic paracenteses		up to 12 weeks	No
Secondary	Time from randomisation to first recurrence of ascites		study period	No
Secondary	Increase in ascites		over 12 weeks	No