Tolvaptan for Ascites in Cirrhotic Patients

Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites

Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.

This is an open label, 12 week dose escalating pilot study of tolvaptan (initiating at 15 mg a day and increasing to 30 mg a day as tolerated in addition to standard ascites treatment) of 10 cirrhotic subjects meeting all inclusion/exclusion criteria. Subjects are monitored for changes in frequency of paracentesis, quantity of ascites removed, and body weight. Additionally, subjects laboratory values were checked frequently during the first days of dosing to ensure tolerability and slow correction/increase in serum sodium.

Inclusion Criteria:

• Patients with cirrhosis of liver confirmed by histology and/or combination of ultrasound or endoscopic examination with laboratory evidence
• Clinically evident ascites treated by diet and/or diuretics
• History of 1 or more therapeutic paracentesis in the previous 6 months.

Exclusion Criteria:

• History of variceal bleeding
• Current or history of Gastrointestinal bleeding within 10 days of screening
• Ascites from another cause other than liver cirrhosis (i.e. cardiac origin, peritoneal infection, or peritoneal carcinoma)
• INR (International normalized ratio) > 3.0, neutrophils <1500 cell/μl, platelets < 40,000/μl
• serum bilirubin > 3 mg/dl
• serum sodium < 125 meQ (milliequivalent)/L
• serum potassium <3.5 meQ/L