This trial is active, not recruiting.

Conditions ascites, cirrhosis
Treatment tolvaptan
Phase phase 4
Sponsor University of Florida
Collaborator Otsuka America Pharmaceutical
Start date March 2012
End date December 2015
Trial size 10 participants
Trial identifier NCT01292304, 156-IST-10-06


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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
tolvaptan (SAMSCA)
Oral administration once daily Dosage will range from 15 mg to 30 mg

Primary Outcomes

Number of patients with worsening ascites
time frame: Week 12

Secondary Outcomes

Number of patients with reduction of ascites
time frame: 12 weeks
Number of Patients with Potentially Clinically Significant Abnormal Labs
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites
Principal investigator Giuseppe (Joseph) Morelli, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by University of Florida.