Tolvaptan for Ascites in Cirrhotic Patients

Phase 4

Completed

• Conditions: Ascites; Cirrhosis
• Interventions: Drug: Tolvaptan

• Registration Number: NCT01292304
• Lead Sponsor: University of Florida

Brief 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.

Study Timeline

• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-09
• Study Start: 2012-03
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Results First Submitted: 2015-05-28
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-30
• Last Update Submitted: 2015-06-30
• Results First Posted: 2015-07-27
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tolvaptan	Tolvaptan	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)	Week 12	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)	12 weeks of study drug	This outcome will provide the number of subjects with a weight increase of \> 2kg from baseline (worsening ascites)

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)	12 weeks	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)	12 weeks	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)	12 weeks of study drug	This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.

Trial Locations

Locations (1)

University of Florida Hepatology; 🇺🇸 Gainesville, Florida, United States