Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136214
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2005-08-25
Brief Title:
Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
A Study of the Cerebral Effect of Pegylated Interferon in Hepatitis C Positive Subjects
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C HCV positive subjects
Detailed Description:
Subjects with non-cirrhotic hepatitis C will have a magnetic resonance imaging MRImagnetic 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 ie 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 Becks 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
MR spectroscopy MRS will measure the cerebral metabolites NAA N-acetyl aspartate Cho choline MI myoinositol and Cr creatine at 3 distinct brain regions ie 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 Becks 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None