Tolvaptan for Ascites in Cirrhotic Patients

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292304
• Other study ID #: 156-IST-10-06
• Status: Completed
• Phase: Phase 4
• First received: February 7, 2011
• Last updated: June 30, 2015
• Start date: March 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Cirrhosis

Intervention

Drug:
• Tolvaptan
Oral administration once daily Dosage will range from 15 mg to 30 mg

Locations

Country	Name	City	State
United States	University of Florida Hepatology	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)	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	Week 12	No
Primary	Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)	This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)	12 weeks of study drug	No
Secondary	Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)	Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing	12 weeks	No
Secondary	Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)	Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L	12 weeks	Yes
Secondary	Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)	This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.	12 weeks of study drug	No