- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136214
Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
A Study of the Cerebral Effect of Pegylated Interferon in Hepatitis C Positive Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Interferon Treated Group
Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests
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Non-treated cohort control
Group undergoing MR brain and neuropsychiatric tests
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratios of Cerebral Metabolites Choline (CH), Myoinisitol (MI) and N-acety Aspartate (NAA)to Creatine (Cr) in 3 Brain Regions Including Basal Ganglia, Frontal Cortex and Left Dorsolateral Prefrontal Cortex
Time Frame: 18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline
|
Evaluation of changes in MR spectroscopy.
reductions in ratio of Cho and MI reflect improvements in cerebral inflammation and improvement in cognition.
Increases in the NAA ratio are suggestive of improvement in cognitive function.
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18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline
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Neurocognitive Tests for Cerebral Function
Time Frame: 18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline and only done in treated group and not controls
|
A battery of pen and paper neurocognitive tests where subject means are reported compared to the normative Z score.
Data is reported at baseline (T1), week 12 on treatment (T2) and 12 weeks after treatment (week 60, T3).
Improvements are increases in the test result compared to baseline as determined against the Z score.
tests performed included Hopkins learning trials (HVLT), a measure of of verbal learning and memory and the Roy-Osterrieth Complex figure test (ROCF) which evaluates visio-spatal abilities, memory, planning and working memory.
Improvements in the score (increases in value compared, either less negative or more positive to the Z score) shown in the table are reflective of improvements in these neurocognitive parameters.
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18 months overall with measures performed at baseline (T1), week 12 (T2) and 12 weeks after end of treatment (T3) with PEG-IFN for 48 weeks which is 60 weeks post baseline and only done in treated group and not controls
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003P000341
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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