Personalized Medicine in HCV Infection: Cognitive Impairments and Brain Anomalies in Chronic Hepatitis C Infected Individuals. Characterization and Potential Reversibility With Direct Antiviral Agents.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in Continuous Performance Test (CPT) score
研究概览
简要总结
The overall aim of this study is to evaluate the prevalence of cognitive impairments and brain anomalies in Chronic Hepatitis C infected individuals and to investigate likely changes in cognition and brain structure and function after treatment with Direct-acting Antivirals (DAAs).
详细描述
Design: Prospective interventional study.
Chronic HCV infected patients who are going to initiate a DAA-based antiviral regimen according to clinical practice will be recruited to participate in the study. Patients will be treated according to the current national and international guidelines for the treatment of HCV chronic hepatitis. The participation in the study will not influence neither the indication for de treatment nor the type of treatment prescribed. The only intervention in this study refers to the performance of extraordinary neuro-psychological evaluations and MRI studies at different times along the study.
Patients and methods:
This study will be performed in a cohort of 80 patients with CHC (≤ F3). The number of subjects required to test effects with sufficient power over the entire cortex varies between cortical measures (cortical thickness: N=39, surface area: N=21, volume: N=81; 10mm smoothing, power=0.8, α =0.05). For subcortical regions this number is between 16 and 76 subjects, depending on the region (Liem et al., 2015). Sample size calculations performed for functional magnetic resonance using values of medium Cohen's d effect size of 0.6 and 0.7 yield sample sizes of 88, 66 respectively to achieve 80% power at a significance level of 0.05 (Guo et al., 2012). Therefore, the sample size estimated in this project would yield enough power to detect small and medium effects size.
The following studies will be conducted:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHC patients 18-75 years old
- •Liver fibrosis ≤ F3 in Fibroscan/liver biopsy
- •Naive or previous failure to a treatment
- •Accept the study and sign the CI
排除标准
- •Does not meet the above criteria
- •VIH or other viral coinfection
- •Hepatocarcinoma
- •Other systemic inflammatory diseases (i.e. RA, etc)
- •Neurodegenerative diseases
结局指标
主要结局
Changes in Continuous Performance Test (CPT) score
时间窗: Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response)
Neuropsychological test to assess Cognitive impairment, particularly Attention and reaction time
次要结局
- Changes in Digit symbol WAIS-III subtest score(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in Letter FAS score(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in Rey Copy Figure(RCF) scores(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Advers events(up to 24 weeks)
- Changes in Rey Auditory Verbal Learning Test (RAVLT) scores(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in cortical thickness(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in Tower of London score(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in Stroop color-word test scores(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in Grooved Pegboard score(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in Digits forward and backward WAIS-III subtest scores(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in Trail Making Test (TMT) Parts A & B scores(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in animal category subtest score(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in cortical surface área assessed by MRI(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Changes in cortical surface volumen assessed by MRI(Basal and 3, 6 and 12 months after the end of treatment (Sustained Viral Response))
- Sustained Viral Response(3, 6 and 12 months after the end of treatment (Sustained Viral Response))