SPARe-2: Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Sponsor

Sanofi (Industry)

Overall Status

Terminated

CT.gov ID

NCT00366795

Collaborator

(none)

241

Enrollment

Locations

Arms

Duration (Months)

11.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

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

Study Design

Study Type:

Interventional

Actual Enrollment :

241 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 in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 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:

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.

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	Sao Paulo		Brazil
7	Sanofi-Aventis Administrative Office	Sofia		Bulgaria
8	Sanofi-Aventis Administrative Office	Laval		Canada
9	Sanofi-Aventis Administrative Office	Santiago		Chile
10	Sanofi-Aventis Administrative Office	Praha		Czech Republic
11	Sanofi-Aventis Administrative Office	Paris		France
12	Sanofi-Aventis Administrative Office	Berlin		Germany
13	Sanofi-Aventis Administrative Office	Kuala Lumpur		Malaysia
14	Sanofi-Aventis Administrative Office	Mexico		Mexico
15	Sanofi-Aventis Administrative Office	Warszawa		Poland
16	Sanofi-Aventis Administrative Office	Bucuresti		Romania
17	Sanofi-Aventis Administrative Office	Moscow		Russian Federation
18	Sanofi-Aventis Administrative Office	Belgrade		Serbia
19	Sanofi-Aventis Administrative Office	Singapore		Singapore
20	Sanofi-Aventis Administrative Office	Barcelona		Spain
21	Sanofi-Aventis Administrative Office	Istanbul		Turkey