SPARe-1: Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Sponsor

Sanofi (Industry)

Overall Status

Terminated

CT.gov ID

NCT00359437

Collaborator

(none)

501

Enrollment

Locations

Arms

Duration (Months)

20.9

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites.

Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants 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).

Condition or Disease	Intervention/Treatment	Phase
Ascites Liver Cirrhosis	Drug: Satavaptan Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

501 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Satavaptan	Drug: Satavaptan oral administration once daily Other Names: SR121463B
Placebo Comparator: Placebo	Drug: placebo oral administration once daily

Arm

Intervention/Treatment

Experimental: Satavaptan

Drug: Satavaptan

oral administration once daily

Other Names:

SR121463B

Placebo Comparator: Placebo

Drug: placebo

oral administration once daily

Outcome Measures

Primary Outcome Measures

Number and time of recurrences of therapeutic paracenteses [up to 12 weeks]

Secondary Outcome Measures

Time from randomisation to first recurrence of ascites [study period]
Increase in ascites [over 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants with cirrhosis of the liver.
Participants 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 > 4 litres of fluid.
at least one other therapeutic paracentesis in the previous 3 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Sanofi-Aventis Administrative Office	Sarajevo		Bosnia and Herzegovina
6	Sanofi-Aventis Administrative Office	Sofia		Bulgaria
7	Sanofi-Aventis Administrative Office	Laval		Canada
8	Sanofi-Aventis Administrative Office	Zagreb		Croatia
9	Sanofi-Aventis Administrative Office	Praha		Czech Republic
10	Sanofi-Aventis Administrative Office	Paris		France
11	Sanofi-Aventis Administrative Office	Berlin		Germany
12	Sanofi-Aventis Administrative Office	Budapest		Hungary
13	Sanofi-Aventis Administrative Office	Natanya		Israel
14	Sanofi-Aventis Administrative Office	Milano		Italy
15	Sanofi-Aventis Administrative Office	Seoul		Korea, Republic of
16	Sanofi-Aventis Administrative Office	Kuala Lumpur		Malaysia
17	Sanofi-Aventis Administrative Office	Porto Salvo		Portugal
18	Sanofi-Aventis Administrative Office	Bucuresti		Romania
19	Sanofi-Aventis Administrative Office	Belgrade		Serbia
20	Sanofi-Aventis Administrative Office	Singapore		Singapore
21	Sanofi-Aventis Administrative Office	Midrand		South Africa
22	Sanofi-Aventis Administrative Office	Barcelona		Spain
23	Sanofi-Aventis Administrative Office	Taipei		Taiwan
24	Sanofi-Aventis Administrative Office	Guildford Surrey		United Kingdom