Neurocognitive Functioning in Patients With Hepatitis C Pre- and Post-Treatment With Antiviral Medication
Recruitment status was Recruiting
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Purpose
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 addresses the hypothesis that neurocognitive and neurochemical abnormalities may occur in individuals with HCV-infection who do not have liver cirrhosis or vasculitic neuropathy, and this may result from a direct effect of HCV on the Central Nervous System (CNS). The purpose of this study is to assess whether infection with the Hepatitis-C virus is associated with changes in thinking skills and brain chemistry, in patients who do not have liver cirrhosis. In addition, we are examining whether such changes in thinking skills and brain chemistry are reversed by antiviral treatment. We are also studying whether factors such as fatigue and depression have an effect on thinking skills in people with Hepatitis-C. In order to take into account the impact of having viral hepatitis, we will be comparing the results of the Hepatitis-C group to the results of a group of patients with Hepatitis-B, and to a group of individuals who do not have Hepatitis.
| Condition |
|---|
|
Hepatitis C Hepatitis B |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | An Investigation of Cognitive Functioning and Brain Metabolites in Patients With Non-Cirrhotic Hepatitis-C Both Pre- and Post-Treatment With Antiviral Medication |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
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)
Contacts and Locations| Contact: Mirela Mrkonjic | 416-603-5800 ext 3217 |
| Canada, Ontario | |
| Liver Clinic, Toronto Western Hospital, UHN. | Recruiting |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Contact: E.J.L. (Jenny) Heathcote, MD 416-603-5914 | |
| Principal Investigator: E.J.L (Jenny) Heathcote, M.D. | |
| Principal Investigator: | E.J.L (Jenny) Heathcote, MD | UHN - Toronto Western Hospital, University of Toronto |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00188201 History of Changes |
| Other Study ID Numbers: | 01-0827-E, EOP-48307 |
| Study First Received: | September 9, 2005 |
| Last Updated: | November 28, 2005 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Hepatitis C neucognitive functions neuropsychological testing antiviral treatment |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis C Hepatitis, Viral, Human Liver Diseases Digestive System Diseases Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013