Tolvaptan for Ascites in Cirrhotic Patients

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Otsuka America Pharmaceutical
• Treatments: Tolvaptan

Criteria

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