Tolvaptan for Ascites in Cirrhotic Patients
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites|
- Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Increase in number of therapeutic paracentesis (removal of > 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing
- Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain) [ Time Frame: 12 weeks of study drug ] [ Designated as safety issue: No ]This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)
- Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing
- Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L
- Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid) [ Time Frame: 12 weeks of study drug ] [ Designated as safety issue: No ]This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.
|Study Start Date:||March 2012|
|Study Completion Date:||January 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability
Oral administration once daily Dosage will range from 15 mg to 30 mg
Other Name: (SAMSCA)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292304
|United States, Florida|
|University of Florida Hepatology|
|Gainesville, Florida, United States, 32610-0277|
|Principal Investigator:||Giuseppe (Joseph) Morelli, MD||University of Florida|