Tolvaptan for Ascites in Cirrhotic Patients

This study has been completed.
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
University of Florida Identifier:
First received: February 7, 2011
Last updated: June 30, 2015
Last verified: June 2015
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.

Condition Intervention Phase
Drug: Tolvaptan
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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.

Enrollment: 10
Study Start Date: March 2012
Study Completion Date: January 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Tolvaptan
Oral administration once daily Dosage will range from 15 mg to 30 mg
Other Name: (SAMSCA)

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.

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01292304

United States, Florida
University of Florida Hepatology
Gainesville, Florida, United States, 32610-0277
Sponsors and Collaborators
University of Florida
Otsuka America Pharmaceutical
Principal Investigator: Giuseppe (Joseph) Morelli, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida Identifier: NCT01292304     History of Changes
Other Study ID Numbers: 156-IST-10-06
Study First Received: February 7, 2011
Results First Received: May 28, 2015
Last Updated: June 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
v2 receptor antagonist

Additional relevant MeSH terms:
Pathologic Processes processed this record on November 27, 2015