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

Liver Cirrhosis Clinical Trial

— SPARe-2  

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 in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00366795
• Other study ID #: EFC6682
• Secondary ID: EudraCT : 2006-0
• Status: Terminated
• Phase: Phase 3
• First received: August 18, 2006
• Last updated: July 17, 2009
• Start date: August 2006
• Est. completion date: December 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 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 241
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Bulgaria	Sanofi-Aventis Administrative Office	Sofia
Canada	Sanofi-Aventis Administrative Office	Laval
Chile	Sanofi-Aventis Administrative Office	Santiago
Czech Republic	Sanofi-Aventis Administrative Office	Praha
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Malaysia	Sanofi-Aventis Administrative Office	Kuala Lumpur
Mexico	Sanofi-Aventis Administrative Office	Mexico
Poland	Sanofi-Aventis Administrative Office	Warszawa
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Serbia	Sanofi-Aventis Administrative Office	Belgrade
Singapore	Sanofi-Aventis Administrative Office	Singapore
Spain	Sanofi-Aventis Administrative Office	Barcelona
Turkey	Sanofi-Aventis Administrative Office	Istanbul
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,  Brazil,  Bulgaria,  Canada,  Chile,  Czech Republic,  France,  Germany,  Malaysia,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  Singapore,  Spain,  Turkey, 

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