Back to resultsTolvaptan for Ascites in Cirrhotic Patients
Primary Purpose
Ascites, Cirrhosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tolvaptan
Sponsored by
About this trial
This is an interventional treatment trial for Ascites focused on measuring Cirrhotic, Tolvaptan, v2 receptor antagonist
Eligibility Criteria
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
Sites / Locations
- University of Florida Hepatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tolvaptan
Arm Description
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
Outcomes
Primary Outcome Measures
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
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)
Secondary Outcome Measures
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
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
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.
Full Information
NCT ID
NCT01292304
First Posted
February 7, 2011
Last Updated
June 30, 2015
Sponsor
University of Florida
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01292304
Brief Title
Tolvaptan for Ascites in Cirrhotic Patients
Official Title
Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Otsuka America Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites, Cirrhosis
Keywords
Cirrhotic, Tolvaptan, v2 receptor antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tolvaptan
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Tolvaptan
Other Intervention Name(s)
(SAMSCA)
Intervention Description
Oral administration once daily Dosage will range from 15 mg to 30 mg
Primary Outcome Measure Information:
Title
Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)
Description
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
Time Frame
Week 12
Title
Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)
Description
This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)
Time Frame
12 weeks of study drug
Secondary Outcome Measure Information:
Title
Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)
Description
Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing
Time Frame
12 weeks
Title
Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)
Description
Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L
Time Frame
12 weeks
Title
Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)
Description
This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.
Time Frame
12 weeks of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe (Joseph) Morelli, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Hepatology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0277
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tolvaptan for Ascites in Cirrhotic Patients
We'll reach out to this number within 24 hrs