Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)

Phase 3

Completed

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

• Registration Number: NCT00358878
• Lead Sponsor: Sanofi

Brief Summary

Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and 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: 2006-07-31
• Study First Submitted QC: 2006-07-31
• Study First Posted: 2006-08-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-26
• Disposition First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Disposition First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

Inclusion Criteria

• Participants with cirrhosis of the liver
• Participants with clinically evident ascites primarily managed by diet and/or diuretics
• Stable treatment of ascites for at least the previous 2 weeks without paracentesis
• Participants having undergone no more than one therapeutic paracentesis in the previous 6 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
Composite endpoint of ascites worsening	at week 12

Secondary Outcome Measures

Name	Time	Method
Composite endpoint of ascites worsening	at week 24
Increase in ascites	at week 12

Trial Locations

Locations (1)

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