Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects

Beth Israel Lahey Health

Status

Completed

Conditions

Hepatitis C

Treatments

Diagnostic Test: MR brain and neuropsychiatric tests

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT00136214

2003P000341

Details and patient eligibility

About

The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.

Full description

Subjects with non-cirrhotic hepatitis C will have a magnetic resonance imaging (MRI)/magnetic resonance (MR) spectroscopy and neuropsychological testing prior to starting interferon. Subjects will have repeat testing following 12 weeks of interferon therapy and again at 12 weeks post interferon therapy.

MR spectroscopy (MRS) will measure the cerebral metabolites, NAA (N-acetyl aspartate), Cho (choline), MI (myoinositol) and Cr (creatine) at 3 distinct brain regions, i.e. basal ganglia and 2 locations within the frontal cortex.

Neuropsychological testing will include tests of the following cognitive domains: executive functioning, memory, language, motor skills and will also include questionnaires pertaining to quality of life (SF-36), mood (Beck's depression inventory) and a self-rating cognitive questionnaire (Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scales [CAARS]).

Control subjects will include non-cirrhotic HCV subjects who are not taking interferon therapy.

Enrollment

22 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults (>18 years old) of both sexes with chronic HCV infection (all genotypes).
Subjects due to start treatment with pegylated interferon-alpha (IFN-a) for HCV eradication.
Subjects with chronic hepatitis C who have elected not to be treated with pegylated-IFN-a
Subjects with mild fibrosis on liver biopsy (stage 0-III/IV fibrosis)
Subjects able to give informed consent.
Subjects with controlled depression currently taking anti-depressant medication.

Exclusion criteria

Subjects with cirrhosis on liver biopsy.
Subjects with active alcohol or drug abuse.
Subjects co-infected with human immunodeficiency virus (HIV).
Subjects with structural brain abnormality, past history of cerebrovascular accident (CVA) or serious head trauma.
Subjects with seizure disorder.
Subjects with any contraindication to IFN therapy.
Subjects with a poor command of the English language.
Subjects with a contraindication to MRI, e.g. pacemaker, claustrophobia.