Effect of Tolvaptan on Cognitive Function in Cirrhosis

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Collaborator: Otsuka America Pharmaceutical
• Treatments: Tolvaptan

Criteria

Inclusion Criteria:

• Cirrhosis diagnosed by liver biopsy or radiological evidence of nodular cirrhotic liver or varices on endoscopy or laboratory features (platelet count <150,000 with an AST/ALT ratio >1).

• History of HE controlled on lactulose and/or rifaximin

• Last HE episode >2 months prior to enrollment and <2 episodes within 6 months

• Mini-mental status exam score ≥25

• Serum sodium <130mg/dl within the last 14 days and the day of enrollment

• Availability of a caregiver

• Able to undergo MR of the head

Exclusion Criteria:

• Uncontrolled HE manifested by MMSE <25

• Alcohol abuse within 3 months

• Illicit drug use within 3 months

• Psychoactive drug use other than regularly scheduled anti-depressants or methadone.

• Contraindication to MR examination (see attached MRI Safety Form)

• Placement of a transjugular intra-hepatic portosystemic shunt (TIPS)

• Creatinine Clearance less than 10 ml/min or undergoing hemodialysis

• HIV infection

• Use of azole medications

• Pregnancy

• Current use of tolvaptan, hypertonic saline or other medical therapies for hyponatremia