Tolvaptan for Ascites in Cirrhotic Patients

NCT ID: NCT01292304

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-01-31

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.

Conditions

Ascites; Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tolvaptan

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

Group Type: EXPERIMENTAL

Tolvaptan

Intervention Type: DRUG

Oral administration once daily Dosage will range from 15 mg to 30 mg

Interventions

Tolvaptan

Oral administration once daily Dosage will range from 15 mg to 30 mg

Intervention Type: DRUG

Other Intervention Names

(SAMSCA)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe (Joseph) Morelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Hepatology

Gainesville, Florida, United States

Countries

United States

Other Identifiers

156-IST-10-06

Identifier Type: -

Identifier Source: org_study_id