NCT00188201

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

November 29, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

November 28, 2005

Conditions

Hepatitis CHepatitis B

Keywords

Hepatitis Cneucognitive functionsneuropsychological testingantiviral treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Clinic, Toronto Western Hospital, UHN.

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis CHepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus Infections

Study Officials

  • E.J.L (Jenny) Heathcote, MD

    UHN - Toronto Western Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirela Mrkonjic

CONTACT

416-603-5800

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

January 1, 2002

Last Updated

November 29, 2005

Record last verified: 2005-09

Locations

CA(1)