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Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver (SPARe-1)

This study has been terminated.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00359437
First received: August 1, 2006
Last updated: July 17, 2009
Last verified: July 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Ascites
Liver Cirrhosis
 Drug: satavaptan (SR121463B)
Drug: placebo
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number and time of recurrences of therapeutic paracenteses [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from randomisation to first recurrence of ascites [ Time Frame: study period ] [ Designated as safety issue: No ]
  • Increase in ascites [ Time Frame: over 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: July 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: satavaptan (SR121463B)
oral administration once daily
Placebo Comparator: 2 Drug: placebo
oral administration once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359437

  Show 24 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00359437     History of Changes
Other Study ID Numbers: EFC4493, EUDRACT: 2006-000132-27, LTS10036
Study First Received: August 1, 2006
Last Updated: July 17, 2009
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Recurrence
 Pathologic Processes
Liver Diseases
Digestive System Diseases
Disease Attributes

ClinicalTrials.gov processed this record on May 22, 2013