Ascites, Liver Cirrhosis
Conditions
Keywords
cirrhotic ascites
Brief summary
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone. The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period. This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence * Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid * Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to repeat therapeutic paracentesis | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Increase in ascites judged by body weight and ascites volume | within 12 weeks |
| frequency of paracentesis | 12 weeks |
| quality of life | 12 weeks |
Countries
Argentina, Australia, Belgium, Canada, Croatia, Czechia, France, Germany, Italy, Spain, Taiwan
Outcome results
None listed