Tolvaptan for Ascites in Cirrhotic Patients



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:11/8/2014
Start Date:March 2012
End Date:January 2015
Contact:Giuseppe (Joseph) Morelli, MD
Email:MORELGJ@MEDICINE.UFL.EDU
Phone:352-273-9500

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
University Of Florida Hepatology
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
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