Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
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|ClinicalTrials.gov Identifier: NCT00136214|
Recruitment Status : Unknown
Verified August 2005 by Beth Israel Deaconess Medical Center.
Recruitment status was: Recruiting
First Posted : August 29, 2005
Last Update Posted : December 24, 2007
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||26 participants|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00136214
|Contact: Valerie Byrnes, MD||617 632 email@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Valerie Byrnes, MD 617-632-1070 firstname.lastname@example.org|
|Principal Investigator: Nezam Afdhal, MD|
|Principal Investigator:||Nezam Afdhal, MD||Beth Israel Deaconess Medical Center|