Effects of Direct-acting Antiviral Agents on Cognitive Function, and Depression in Chronic Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Cognitive performance
研究概览
简要总结
Minimal hepatic encephalopathy (MHE) is an important clinical variant of hepatic encephalopathy (HE), which occurs in up to 60-70% of patients with cirrhosis. The condition comprises a cognitive impairment, observed in patients with cirrhosis who have no clinical evidence of overt hepatic encephalopathy (OHE). It is associated with an increased incidence of road traffic accidents, reduced quality of life and it affects the ability to perform tasks of daily living. Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. In addition, studies have shown that viral eradication may improve cognition when given interferon based regimens for HCV. With the available of safe, efficacious, all oral regimens for HCV, we plan to prospectively analyse the change in mood, depression and cognitive function in response to DAA therapy, in relation to outcomes of treatment.
详细描述
Investigations will be performed according to the Declaration of Helsinki and approval of the enrolment as well as the usage of patient blood samples for research purpose will be obtained from the institutional ethics committee, and written informed consent will be obtained from all patients.The primary analysis upon which the sample size consideration was based involved the comparison of the SVR subgroup and the subgroup of patients without SVR. For the sample size calculation, we a two-factorial design (time course × SVR) with the use of a two-way analysis of variance (ANOVA) analysis, a significance level of 5% and a statistical power of at least 80% to detect a medium effect size (d = 0.5) and thus to show a significant group difference. Based on this background, the optimal sample size is calculated to be a total of 102 subjects. To consider asymmetric subgroups and to allow for a moderate dropout rate and additional calculations (secondary study objectives), we aim to include a total of at least 150 study participants in each group with 25 healthy volunteers as controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Age 18-65 years and chronic HCV infection.
- •Group A: Patients with hepatitis C (Non-cirrhotic) [n= 150]
- •Group B: Patients with hepatitis C related compensated-cirrhosis [n= 150]
- •Group C: Healthy volunteers [n= 25]
排除标准
- •Current overt hepatic encephalopathy or during the last 1 month
- •TIPS (transjugular intra- hepatic porto-systemic shunt)
- •elective surgery planned within the next 8 weeks
- •unable to give informed consent
- •HIV infection
- •chronic respiratory insufficiency
- •current infection and receiving antibiotics
- •renal failure (serum creatinine ≥ 1.5 mg/l)
- •hepatocellular carcinoma,
- •patient with other neurological disease
- •intake of sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil, neuromuscular blocking agents)
结局指标
主要结局
Cognitive performance
时间窗: 90 days after treatment completion
Computerized battery (Reaction times, simple and choice, visual memory, Number connection test, and Inhibitory Control Test)
Cognitive performance using conventional tests
时间窗: 90 days after treatment completion
Psychometric hepatic encephalopathy score (PHES), Indian Version.
HRQOL by SF-36
时间窗: 90 days after treatment completion
次要结局
- Depression Scale(90 days after treatment completion)
研究者
Madhumita Premkumar
Assistant professor, Department of heaptology
Post Graduate Institute of Medical Education and Research, Chandigarh