Satavaptan for the Prevention of Ascites Recurrence in Pa... | NCT00366795

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

NCT00366795

Sponsor

Sanofi

Status

Terminated

Last Update Posted

May 18, 2016Estimated

Enrollment

241Actual

Phase

Phase 3

Conditions

Ascites
Liver Cirrhosis

Interventions

Satavaptan
placebo

Countries

United States
Argentina
Australia
Belgium
Bosnia and Herzegovina
Brazil
Bulgaria
Canada
Chile
Czechia
France
Germany
Malaysia
Mexico
Poland
Romania
Russia
Serbia
Singapore
Spain
Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was terminated due to safety reason.

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Aug 18, 2006

First Submission Date that Met QC Criteria

Aug 18, 2006

First Posted Date

Aug 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 18, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 18, 2016

Certification/Extension First Posted Date

May 18, 2016Estimated

Last Update Submitted Date

Apr 18, 2016

Last Update Posted Date

May 18, 2016Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

241Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Satavaptan	Experimental		Drug: Satavaptan
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Satavaptan	Drug	oral administration once daily	Satavaptan	SR121463B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and time of recurrences of therapeutic paracenteses		up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time from randomisation to first recurrence of ascites		study period
Increase in ascites		over 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Malvern	Pennsylvania	19355	United States
Sanofi-Aventis Administrative Office

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21836029	Derived	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis

ID	Type	Description	Link
EudraCT : 2006-000132-27
LTS10036

ID	Term
D001201	Ascites
D008103	Liver Cirrhosis