NCT00877149已完成4 期
A Single-arm, Multicenter, Open-label, 52-week Treatment, Extension Study to CLDT600ACN04 Study to Evaluate the Efficacy (Including Histological Improvement) and Safety in Fourth to Sixth Year of Telbivudine Treatment in Patients With Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.
研究概览
简要总结
The purpose of this trial is to provide data of absence of inflammation in patient liver histology after long-term telbivudine treatment and thus help investigators to make a comprehensive judgment on treatment discontinuation in selected patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient completed study CLDT600ACN04 study and will be available to immediately rollover into this study without discontinuation of study drug.
- •Patient was not discontinued from the previous CLDT600ACN04 study.
- •Adult patients with CHB (HBeAg positive or HBeAg negative).
- •HBV DNA PCR undetectable in recent 12 months.
排除标准
- •Pregnant or breastfeeding, or has plan of pregnant during study period.
- •Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV at screening visit.
- •Patient has received within the past 12 months any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
A
Experimental
干预措施: telbivudine/LDT600 (Drug)
结局指标
主要结局
To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.
时间窗: Visit 2 (week 1)
次要结局
- To assess the HBV DNA PCR negativity at 4th-6th year treatment with telbivudine (LDT), in selected patients who have completed study CLDT600ACN04 and will continue telbivudine treatment(weeks 1, 24, 52 and 24 weeks post-treatment)
- To evaluate the percentage of patients with HBeAg loss and/or gain of detectable level of HBeAb in HBeAg positive CHB at baseline of NV-02B-007 or NV-02B-015 studies(weeks 24 and 52, 24 weeks post-treatment)
- To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion(weeks 24, 52 and 24 weeks post-treatment)
- To evaluate the changes in Knodell inflammatory and fibrosis scores from biopsy at study entry compared to biopsy at baseline of studies NV-02B-007 and NV-02B-015(Visit 2 (week 1))
研究者
研究点 (4)
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