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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon Treated Group | Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests |
| |
| Non-treated cohort control | Group undergoing MR brain and neuropsychiatric tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR brain and neuropsychiatric tests | Diagnostic Test |
|
| 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 | 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. | 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 |
| Neurocognitive Tests for Cerebral Function | 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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HCV positive patients Subjects with cirrhosis, active alcohol or drug abuse, co-infection with human immunodeficiency virus (HIV), structural brain abnormality, past history of cerebrovascular accident (CVA), serious head trauma, and seizure disorder were excluded. Other exclusions were contraindication to PIFN therapy, current psychiatric disorder or contraindications to MRI e.g., pacemaker and claustrophobia.
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| Name | Affiliation | Role |
|---|---|---|
| Nezam Afdhal, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22027578 | Result | Byrnes V, Miller A, Lowry D, Hill E, Weinstein C, Alsop D, Lenkinski R, Afdhal NH. Effects of anti-viral therapy and HCV clearance on cerebral metabolism and cognition. J Hepatol. 2012 Mar;56(3):549-56. doi: 10.1016/j.jhep.2011.09.015. Epub 2011 Oct 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interferon Treated Group | Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests MR brain and neuropsychiatric tests |
| FG001 | Non-treated Cohort Control | Group undergoing MR brain and neuropsychiatric tests MR brain and neuropsychiatric tests |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interferon Treated Group | Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests MR brain and neuropsychiatric tests |
| BG001 | Non-treated Cohort Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | One patient dropped out secondary to claustrophobia and was unable to complete MR portion of study | Posted | Mean | Standard Deviation | ratio | 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 |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interferon Treated Group | Group treated with PEG-Interferon and ribavirin and undergoing MR brain and neuropsychiatric tests MR brain and neuropsychiatric tests |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue, fu like symptoms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Intolerant to interferon |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nezam Afdhal | BIDMC | 617632118 | nafdhal@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Group undergoing MR brain and neuropsychiatric tests
MR brain and neuropsychiatric tests
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Non-treated Cohort Control | Group undergoing MR brain and neuropsychiatric tests MR brain and neuropsychiatric tests A small but significant improvement in neurocognitive function secondary to the practice effect was seen in both HCV controls and HCV subjects during treatment. |
|
|
|
| Primary | Neurocognitive Tests for Cerebral Function | 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. | Posted | Mean | Standard Deviation | Z-score | 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 |
|
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 0 |
| 15 |
| EG001 | Non-treated Cohort Control | Group undergoing MR brain and neuropsychiatric tests MR brain and neuropsychiatric tests | 0 | 7 | 0 | 7 | 0 | 7 |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| HVLT, Verbal Learning Total, T3 |
|
| ROCF, T1 |
|
| ROCF, T2 |
|
| ROCF,T3 |
|
| Wilcoxon (Mann-Whitney) |
| < 0.05 |
| Superiority |
| Comparison between controls and IFN treated at time point 2 on change between scores for HVLT | Wilcoxon (Mann-Whitney) | >0.05 | Superiority |
| Comparison between controls and IFN treated at time point 2 on change between scores for ROCF | Wilcoxon (Mann-Whitney) | >0.05 | Superiority |