NCT00227149已完成不适用
Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C Infection and a Former (Peg)Interferon Alfa-2b-Based Therapy
University of Wuerzburg1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2005年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 1
研究概览
简要总结
This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy.
M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen
Questions:
- Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment?
- At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication?
- At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life?
- In the absence of clinically significant liver damage in patients with chronic hepatitis C - does the mere presence of the hepatitis C virus have any significant influence on neurocognitive or attentional performance?
- Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, emotional state and - above all - is neurocognitive performance significantly improved even in the absence of severe liver damage?
详细描述
This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy.
M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen
Questions:
- Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment?
- At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication?
- At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life?
- Can the results of the current and previous studies be confirmed by alternative / additional psychometric instruments in specified subsample? (Fatigue Impact Scale; FIS-D, SF-36)
- In the absence of clinically significant liver damage in patients with chronic hepatitis C - does the mere presence of the hepatitis C virus have any significant influence on neurocognitive or attentional performance?
- Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, is emotional state and - above all - neurocognitive performance significantly improved even in the absence of severe liver damage?
Methods:
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
- 否
入选标准
- •Patients with chronic hepatitis C and indication for interferon-based antiviral therapy.
- •Written informed consent to study participation, especially to long-term follow-up monitoring of psychiatric and neurocognitive side effects of combination therapy with (peg)interferon alfa-2b and ribavirin.
- •Age of study participants: between 18 and 65 years.
- •All patients need to have documented antibodies to hepatitis C virus (HCV) and circulating HCV-RNA as measured by reverse-transcription polymerase chain reaction (Cobas Amplicor HCV Monitor™ test, Roche Diagnostics)
排除标准
- •Insufficient knowledge of the German language or cognitive impairment (due to the indispensable application of questionnaires and the TAP, test battery of attentional performance).
- •Further Exclusion Criteria:
- •Age under 18 years or over 65 years
- •Coinfections such as hepatitis B virus or human immunodeficiency virus
- •Severe internal diseases (e.g., cancer, ischemic heart disease, autoimmune disease)
- •Major depressive disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] criteria), psychosis, active intravenous drug use or alcohol abuse.
- •These additional exclusion criteria are important in order to avoid interfering or confounding effects by other variables that are not linked to the hepatitis C infection.
研究者
研究点 (1)
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