Tolvaptan for Ascites in Cirrhotic Patients

University of Florida

Status and phase

Completed

Phase 4

Conditions

Cirrhosis

Ascites

Treatments

Drug: Tolvaptan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01292304

156-IST-10-06

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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