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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188201
First received: September 9, 2005
Last updated: November 28, 2005
Last verified: September 2005
  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
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Estimated Enrollment: 150
Study Start Date: January 2002
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188201

Contacts
Contact: Mirela Mrkonjic 416-603-5800 ext 3217

Locations
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
Investigators
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 C
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014