NCT01264107已完成不适用
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
Bukwang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2009年4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
- 37
- 试验地点
- 1
- 主要终点
- Proportion of patients with sustained antiviral activity effect
研究概览
简要总结
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients is currently clevudine treatment.
- •Patients with HBV DNA < 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine
- •Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
排除标准
- •Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- •Patient is pregnant or breast-feeding.
- •Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease.
- •Patient, in the opinion of the investigator, unsuitable for the study.
- •Showing Muscle-related Symptom who any other evidence.
结局指标
主要结局
Proportion of patients with sustained antiviral activity effect
时间窗: at week 48
次要结局
- The change of sAg(at week 48)
- Proportion of sAg loss(at week 48)
- The change of HBV DNA form the baseline(at week 48)
- Proportion of patients with ALT normalization(at week 48)
- Proportion of HBeAg loss/seroconversion(at week 48)
研究者
研究点 (1)
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