Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
Recruitment status was Recruiting
The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Study of the Cerebral Effect of Pegylated Interferon in Hepatitis C Positive Subjects|
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||December 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136214
|Contact: Valerie Byrnes, MD||617 632 firstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Valerie Byrnes, MD 617-632-1070 email@example.com|
|Principal Investigator: Nezam Afdhal, MD|
|Principal Investigator:||Nezam Afdhal, MD||Beth Israel Deaconess Medical Center|