NCT01292304

Tolvaptan for Ascites in Cirrhotic Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ascites
• Cirrhosis

Interventions

Type	Name	Description
DRUG	Tolvaptan	Oral administration once daily Dosage will range from 15 mg to 30 mg

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2011-02-09
• Last updated: 2015-07-27
• Results posted: 2015-07-27

Locations

1 site across 1 country: United States