Status:
TERMINATED
Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver
Lead Sponsor:
Sanofi
Conditions:
Ascites
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00366795
Start Date
August 1 2006
End Date
December 1 2008
Last Update
May 18 2016
Active Locations (21)
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1
Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, United States, 19355
2
Sanofi-Aventis Administrative Office
San Isidro, Argentina
3
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
4
Sanofi-Aventis Administrative Office
Diegem, Belgium