A multicenter, randomized, double-blind, placebo-controlled study evaluating the effects of terlipressin in patients with cirrhosis and recurrent ascites treated with paracentesis and intravenous albumin. -TERAS Study

INTERVENTION: Trade Name: Glypressin Product Name: Glypressin Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: terlipressin acetate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1 mg/5 ml‐ Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Intravenous bolus use (Noncurrent) CONDITION: Cirrhosis with refractory ascites requiring therapeutic paracentesis; MedDRA version: 8.1 Level: PT Classification code 10003445 Term: refractory ascites PRIMARY OUTCOME: Main Objective: To compare the effect of the combination of "terlipressin (1 mg twice daily) plus albumin" versus "placebo plus albumin" on the number of paracentesis procedures performed during 6 months of treatment. Primary endpoint(s): The primary endpoint will be the mean number of paracentesis procedures per month, assessed over 6 months. Secondary Objective: - To compare the number of serious complications of cirrhosis (gastrointestinal bleeding, infection of ascitic fluid, encephalopathy, death), tolerability (premature discontinuation of treatment, cardiovascular complications); - To compare the number of days of hospitalization; to compare the total volume of ascites removed during the 6 months of the study; - Compare the time to first rehospitalization for paracentesis. INCLUSION CRITERIA: 1- Men or women aged 18 to 70 years with cirrhosis and refractory ascites admitted to the day hospital for therapeutic paracentesis. - Cirrhosis is defined according to histological criteria or, failing that, based on a combination of standard clinical, biological, or radiological criteria. - Refractory ascites is defined according to the criteria of the "International Ascites Club": non-mobilizable or recurrent ascites despite well-conducted medical treatment (low-salt diet and diuretic therapy). 2- Life-threatening prognosis not within 2 months following randomization. 3- The patient must have previously given their free, informed, and written consent in the absence of severe encephalopathy. 4- Beneficiary of a social security scheme or be a dependent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 year