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

Primary Purpose

Ascites, Liver Cirrhosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Satavaptan
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascites focused on measuring Ascites, Liver Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Satavaptan

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Composite endpoint of ascites worsening

Secondary Outcome Measures

Composite endpoint of ascites worsening
Increase in ascites

Full Information

First Posted
July 31, 2006
Last Updated
April 26, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00358878
Brief Title
Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)
Acronym
CATS
Official Title
Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites, Liver Cirrhosis
Keywords
Ascites, Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
463 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Satavaptan
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Satavaptan
Other Intervention Name(s)
SR121463B
Intervention Description
oral administration once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration once daily
Primary Outcome Measure Information:
Title
Composite endpoint of ascites worsening
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
Composite endpoint of ascites worsening
Time Frame
at week 24
Title
Increase in ascites
Time Frame
at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Buenos Aires
Country
Argentina
Facility Name
Sanofi-Aventis Administrative Office
City
Cove
State/Province
New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Diegem
Country
Belgium
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Zagreb
Country
Croatia
Facility Name
Sanofi-Aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Natanya
Country
Israel
Facility Name
Sanofi-Aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Madrid
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford
State/Province
Surrey
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21836029
Citation
Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Gines P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.
Results Reference
derived

Learn more about this trial

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

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