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

Phase 3

Terminated

• Conditions: Liver Cirrhosis; Ascites
• Interventions: Drug: placebo; Drug: Satavaptan

• Registration Number: NCT00359437
• Lead Sponsor: Sanofi

Brief 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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-01
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-02
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-25
• Disposition First Submitted QC: 2016-04-25
• Last Update Submitted: 2016-04-25
• Disposition First Posted: 2016-05-24
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 501

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Satavaptan	Satavaptan	-

Primary Outcome Measures

Name	Time	Method
Number and time of recurrences of therapeutic paracenteses	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Increase in ascites	over 12 weeks
Time from randomisation to first recurrence of ascites	study period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford Surrey, United Kingdom