A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- PCR negativity
研究概览
简要总结
This study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR negativity.
详细描述
This study will be multicenter, open-label and observational data collection of patients on telbivudine who meet baseline characteristics defined as the majority of patients seen in the clinic setting. Data collection will take place after enrollment, at Week 12, 24, 52, 76 and 104 for efficacy assessments. In patients who discontinue observational drug earlier, clinical information would be kept following for assessment as well.
Study purpose:
This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the Roadmap Concept in chronic hepatitis B treatment.
Objectives:
Primary:
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
- •Male or female 18 to 65 years of age
- •Documented chronic hepatitis B defined by ALL of following:
- •Clinical history compatible with compensated chronic hepatitis B
- •Detectable serum hepatitis B surface antigen (HBsAg)> 6 months and at the screening visit.
排除标准
- •Pregnant or nursing
- •co-infection with hepatitis C virus (HCV) or HIV
- •Clinical or imaging diagnosis of cirrhosis
- •Evidence of decreased renal function of creatinine >(=)2x ULN
结局指标
主要结局
PCR negativity
时间窗: week 104
HBeAg seroconversion rate
时间窗: week 104
次要结局
- Rate of ALT normalization(week 104)
- Genotypic resistance(week 104)