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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center Schering-Plough |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00136214 |
The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.
Condition |
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Hepatitis C |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Study of the Cerebral Effect of Pegylated Interferon in Hepatitis C Positive Subjects |
Estimated Enrollment: | 26 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Valerie Byrnes, MD | 617 632 1070 | vbyrnes@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Valerie Byrnes, MD 617-632-1070 vbyrnes@bidmc.harvard.edu | |
Principal Investigator: Nezam Afdhal, MD |
Principal Investigator: | Nezam Afdhal, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | 2003P-000341 |
Study First Received: | August 25, 2005 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00136214 History of Changes |
Health Authority: | United States: Institutional Review Board |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Interferons Hepatitis, Viral, Human Hepatitis C |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases |
Digestive System Diseases Flaviviridae Infections Hepatitis, Viral, Human Hepatitis C |