NCT01337791已完成4 期
Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
Southeast University, China1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety
研究概览
简要总结
Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored. In this open-label, prospective study from the second trimester to post-partum week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated alanine aminotransferase levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 20-40 years
- •gestational age between 12-30 weeks
- •serum HBsAg and HBeAg positivity
- •HBV DNA levels >6log10 copies/mL
- •ALT >1x ULN (40 IU/mL) and < 10x ULN.
排除标准
- •co-infection with hepatitis A, C, D, E or HIV
- •evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity
- •concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
- •clinical signs of threatened miscarriage in early pregnancy
- •evidence of fetal deformity by 3-dimensional ultrasound examination
- •the biological father of the child had CHB
研究组 & 干预措施
control
No Intervention
干预措施: Telbivudine treatment (Drug)
结局指标
主要结局
The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety
时间窗: From late pregnancy to 28 weeks of postpartum
次要结局
- Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg(From late pregnancy to 28 weeks of postpartum)
研究者
研究点 (1)
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