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Neurocognitive Functioning in Patients With Hepatitis C Pre- and Post-Treatment With Antiviral Medication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188201
Recruitment Status : Unknown
Verified September 2005 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : November 29, 2005
Information provided by:
University Health Network, Toronto

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 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 or disease
Hepatitis C Hepatitis B

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Study Type : Observational
Enrollment : 150 participants
Observational Model: Defined Population
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
Study Start Date : January 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00188201

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Contact: Mirela Mrkonjic 416-603-5800 ext 3217

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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.         
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: E.J.L (Jenny) Heathcote, MD UHN - Toronto Western Hospital, University of Toronto
Layout table for additonal information Identifier: NCT00188201    
Other Study ID Numbers: 01-0827-E
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 29, 2005
Last Verified: September 2005
Keywords provided by University Health Network, Toronto:
Hepatitis C
neucognitive functions
neuropsychological testing
antiviral treatment
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections