Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia

Main Inclusion Criteria:

• Subjects with any form of cirrhosis with ascites and who had at least 1 paracentesis of at least 4 liter in the last 6 months.
• Dose of diuretics of spironolactone and furosemide was to be stable for at least one week prior to the screening visit or subject was refractory to diuretics.
• Subjects had to have been on a salt restricted diet (< 5.2 grams sodium/day, 90 mmol) during the screening period prior to the trial drug administration.
• Other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration.
• Child-Pugh B and C liver cirrhosis score lower than 12.
• Subjects with hyponatraemia with sodium level between 120 and 132 mmol/l or normonatraemia with sodium level between 133 and 145 mmol/l measured at screening visit and day 1.

Main Exclusion Criteria:

• Women of child bearing potential (WOCBP)
• Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt
• Liver transplantation
• Budd-Chiari syndrome
• Unstable hepatic disease (acute hepatitis, AST or ALT > 5 x upper limit of normal, bilirubin > 10 mg/dL)