Clinical trial NCT01292304: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ascites
Cirrhosis
Keywords: Cirrhotic
Tolvaptan
v2 receptor antagonist
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2011-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)
timeFrame: Week 12
measure: Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)
timeFrame: 12 weeks of study drug
Secondary outcomes:
measure: Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)
timeFrame: 12 weeks
measure: Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)
timeFrame: 12 weeks
measure: Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)
timeFrame: 12 weeks of study drug
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Hepatology
state: Florida
Study officials:
affiliation: University of Florida
name: Giuseppe (Joseph) Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References: