A Study of the Cerebral Effect of Pegylated Interferon in Hepatitis C Positive Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Neurocognitive Tests for Cerebral Function
研究概览
简要总结
The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Neurocognitive Tests for Cerebral Function
时间窗: 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.
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
时间窗: 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.
次要结局
未报告次要终点
研究者
Nezam H. Afdhal
Professor of Medicine, Part-time
Beth Israel Deaconess Medical Center