Effect of Tolvaptan on Cognitive Function in Cirrhosis

This study is currently recruiting participants.

Verified December 2012 by Hunter Holmes Mcguire Veteran Affairs Medical Center

Sponsor:

Collaborator:

Otsuka America Pharmaceutical

Information provided by (Responsible Party):

Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center

ClinicalTrials.gov Identifier:

NCT01556646

First received: March 15, 2012

Last updated: December 10, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 15, 2012

Last Updated Date

December 10, 2012

Start Date ^ICMJE

April 2011

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cognitive performance [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01556646 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Brain MR Spectroscopy [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Brain Diffusion Tensor Imaging [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Health-related Quality of Life [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Tolvaptan on Cognitive Function in Cirrhosis

Official Title ^ICMJE

Effects of Tolvaptan on Cognitive Function, Brain Metabolism and Quality of Life in Hyponatremic Cirrhotics With Hepatic Encephalopathy: A Prospective Clinical Trial

Brief Summary

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

Detailed Description

Baseline assessment will include a

battery of eight cognitive tests
Health related quality of life
MRI head evaluating MR spectroscopy and diffusion tensor imaging

Patients will then be given tolvaptan 15-30mg qd for 14 days after which the tests will be repeated. During the first 3 days of tolvaptan administration, patients will be admitted and serum sodium will be drawn every 8 hours. 24 hr urine collection will also be performed.

Between the initiation and end of tolvaptan, patients will be seen at least every 3-5 days in between.

Participation will be terminated in case patients get transplanted or develop overt HE in between.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cirrhosis
Hepatic Encephalopathy
Hyponatremia

Intervention ^ICMJE

Drug: Tolvaptan

15 to 30mg qd titrated to sodium concentration

Other Name: Samsca

Study Arm (s)

Experimental: Tolvaptan

Open label study of tolvaptan. First 3 days as an inpatient then outpatient for the remainder of the study

Intervention: Drug: Tolvaptan

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jasmohan S Bajaj, MD

804 675 5802

jsbajaj@vcu.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01556646

Other Study ID Numbers ^ICMJE

Bajaj 01720

Has Data Monitoring Committee

Responsible Party

Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center

Study Sponsor ^ICMJE

Hunter Holmes Mcguire Veteran Affairs Medical Center

Collaborators ^ICMJE

Otsuka America Pharmaceutical

Investigators ^ICMJE

Principal Investigator:

Jasmohan S Bajaj, MD

Hunter Holmes McGuire VA Medical Center

Information Provided By

Hunter Holmes Mcguire Veteran Affairs Medical Center

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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