Status:
UNKNOWN
Neurocognitive Functioning in Patients With Hepatitis C Pre- and Post-Treatment With Antiviral Medication
Lead Sponsor:
University Health Network, Toronto
Conditions:
Hepatitis C
Hepatitis B
Eligibility:
All Genders
18-65 years
Brief Summary
The estimated global prevalence of hepatitis C (HCV) infection is approximately 3% (170 million individuals). In Canada there are an estimated 240,000 people infected with HCV. The current study addre...
Detailed Description
The current proposal addresses the hypothesis that neurocognitive and neurochemical abnormalities may occur in individuals with HCV-infection who do not have liver cirrhosis or vasculitic neuropathy, ...
Eligibility Criteria
Inclusion
- patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada
- Fluent in English
- Men and women between the ages of 18 and 65
- Subjects must provide written informed consent to participate
- Control subjects: negative for both HBV, HCV, and HIV
- Additional Inclusion Criteria For HCV and HBV patients:
- patient is a candidate for antiviral treatment
- non-cirrhotic as determined by recent liver biopsy (\<2 years prior to assessment)
- HCV subjects: positive for HCV RNA, negative for HBV and HIV
- HBV subjects: positive for HBV RNA and negative for HCV and HIV
Exclusion
- presence of any of the following medical conditions:
- Thyroid dysfunction, or other endocrine disorder
- Major psychiatric disease, especially major depression and bipolar disorder
- Vitamin B12 or folate deficiency
- Unstable cardiovascular disease (especially atrial fibrillation)
- Unstable diabetes
- Haemophilia (depending on frequency of medication usage)
- The presence of other viral infections (HIV; syphilis)
- Use of pharmaceuticals known to affect cognitive function
- Current alcohol use greater than 2 units per day, or prior history of alcoholism
- Use of illicit drugs within 2 years, or prior prolonged history
- History of intravenous drug use within the past 5 years
- History of any of the following neurological conditions: head injury with loss of consciousness greater than 30min., history of stroke, dementia, seizure disorder,recent substance abuse disorder (within 2 years), learning disability
- Postmenopausal and perimenopausal female participants, unless hormone replacement therapy has been administered consistently for 2 years (on the basis that they may have concentration and memory dysfunction related to cholinergic deficits)
Key Trial Info
Start Date :
January 1 2002
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00188201
Start Date
January 1 2002
Last Update
November 29 2005
Active Locations (1)
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1
Liver Clinic, Toronto Western Hospital, UHN.
Toronto, Ontario, Canada, M5T 2S8