Effect of Tolvaptan on Cognitive Function in Cirrhosis

NCT01556646 | Completed Phase 3

• 1 other identifier: Bajaj 01720
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cirrhosis; Hepatic Encephalopathy; Hyponatremia

Keywords

Cirrhosis; Hepatic Encephalopathy; Hyponatremia; Brain MRI; Health-related quality of life; cognitive function

Outcome Measures

Primary Outcomes (1)

• Cognitive performance

  14 days

Secondary Outcomes (3)

• Brain MR Spectroscopy

  14 days

• Brain Diffusion Tensor Imaging

  14 days

• Health-related Quality of Life

  14 days

Study Arms (1)

Tolvaptan

EXPERIMENTAL

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

Drug: Tolvaptan

Interventions

Tolvaptan DRUG

15 to 30mg qd titrated to sodium concentration

Also known as: Samsca

Tolvaptan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy; Hyponatremia

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jasmohan S Bajaj, MD

  Hunter Holmes McGuire VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 16, 2012
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

US (1)