The Effect of Antiviral Therapy With Pegylated Interferon-alpha for Chronic Hepatitis C and B on Auditory Disability: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- to assess the rate of auditory disability induced by pegylated interferon alpha for HCV and HBV.
研究概览
简要总结
The aim of the study is to assess the effect of antiviral therapy with pegylated interferon alpha for hepatitis C and B on auditory disability as there are reports in the English literature on auditory disability caused by interferon alpha.
详细描述
The population to be studied: Patients with chronic hepatitis C or B treated by pegylated interferon- alpha.
Trial Design Primary end-point: to assess the rate of auditory disability induced by pegylated interferon alpha for hepatitis C virus (HCV) and hepatitisB virus (HBV).
Secondary end-point: to investigate the outcome of auditory disability induced by pegylated interferon alpha for HCV and HBV.
Type/design of trial to be conducted: Prospective, longitudinal and controlled trial.
In each participant, base line conventional auditory assessment will be performed as well as during and at the end of treatment. The results will be compared to base-line measurements.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic hepatitis C virus infection who will receive anti viral treatment consists of PEG-IFN-alpha-2a or 2b combined with ribavirin,
- •Patients with chronic hepatitis B who receive anti-viral treatment with PEG-IFN-alpha 2a (Pegasys)
- •Age 18-70 who are eligible for anti viral treatment.
- •Patients who attend and are treated in the Liver Unit of Haifa and Western
- •Galilee District of Clalit Health Services and Carmel Medical Center will be recruited.
- •Patients with all HCV genotypes will be included and will be treated by the standard-of-care therapy for hepatitis C: 48 weeks for genotypes 1 or
- •Patients and 24 weeks for genotypes 2 or
- •Virological response will be determined at week 12 of treatment. In non-responders therapy will be discontinued.
- •In those patients with genotype 1 and "'slow virological response", 72 weeks of therapy will be considered. Included will be also patients with chronic hepatitis B receiving PEG-IFN alpha 2a for up to 48 weeks.
排除标准
- 未提供
结局指标
主要结局
to assess the rate of auditory disability induced by pegylated interferon alpha for HCV and HBV.
时间窗: Two years
次要结局
- to investigate the outcome of auditory disability induced by pegylated interferon alpha for HCV and HBV.(Two years)
研究者
Eli Zuckerman
Director of Liver Unit Carmel Medical Center
Carmel Medical Center