Tolvaptan for Ascites in Cirrhotic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292304
Recruitment Status : Completed
First Posted : February 9, 2011
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
University of Florida

February 7, 2011
February 9, 2011
May 28, 2015
July 27, 2015
July 27, 2015
March 2012
December 2014   (Final data collection date for primary outcome measure)
  • Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid) [ Time Frame: 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) [ Time Frame: 12 weeks of study drug ]
    This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)
Proportion of patients with ascites worsening [ Time Frame: Week 12 ]
Increase in # of therapeutic paracentesis (removal of > 2 litres of ascites fluid) or weight increase of > 2kg from baseline
Complete list of historical versions of study NCT01292304 on Archive Site
  • Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
Safety of Tolvaptan in combination with standard treatment for ascites [ Time Frame: 12 weeks ]
Evaluation of TEAE
Not Provided
Not Provided
Tolvaptan for Ascites in Cirrhotic Patients
Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites
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.
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.
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Ascites
  • Cirrhosis
Drug: Tolvaptan
Oral administration once daily Dosage will range from 15 mg to 30 mg
Other Name: (SAMSCA)
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
Intervention: Drug: Tolvaptan
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2015
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Florida
University of Florida
Otsuka America Pharmaceutical
Principal Investigator: Giuseppe (Joseph) Morelli, MD University of Florida
University of Florida
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP