Tolvaptan for Ascites in Cirrhotic Patients

Completed · Phase 4

Conditions studied: Ascites, Cirrhosis

In brief

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.

Key facts

Study ID

NCT01292304

Run by

University of Florida

People needed

10

Starts

2012-03-01

Expected to finish

2015-01-01

Last updated by the study team

2015-07-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Florida Hepatology — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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