Satavaptan for 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: NCT00366795
• Lead Sponsor: Sanofi

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-18
• Study First Submitted QC: 2006-08-18
• Study First Posted: 2006-08-21
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-18
• Disposition First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Disposition First Posted: 2016-05-18
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 241

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.

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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.

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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; 🇹🇷 Istanbul, Turkey