A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) Versus Placebo in Pediatric Subjects With Chronic Hepatitis B Virus (HBV) Infection Who Are HBeAg-Positive
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 16
- 主要终点
- Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Entecavir
Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
干预措施: Entecavir (Drug)
Placebo
Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
时间窗: At Week 48
Suppression=HBV DNA\<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.
次要结局
- Percentage of Participants Who Achieved Sustained HBeAg Seroconversion During Off-treatment Follow up Among Participants Who Achieved HBeAg Seroconversion at End of Dosing (EOD).(Week 48, EOD (2 years))
- Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48(At Week 48)
- Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 (Undetectable HBeAg and Presence of Anti-HBeAb)(At Week 48)
- Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48(At Week 48)
- Histological Analysis (Percentage) Among Participants With Available Liver Biopsy Data(Between weeks 48 and 96)
- Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48(At Week 48)
- Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4)(Day 1 through Week 48 on blinded therapy)
- Number of Participants With Adverse Events (Including Palatability Issues), SAEs, Discontinuous Due to Adverse Events, and HBV Disease Progression Through Week 48(Day 1 through Week 48 on blinded therapy)
- Percentage of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression Through Week 96(Day 1 through Week 96)
- Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued)(Day 1 through Week 48 on blinded therapy)
- Percentage of Participants Who Maintained HBeAg Seroconversion at Week 96 (End of Blinded Therapy) Among Participants With HBeAg Seroconversion at Week 48(At Week 96)
- Percentage of Participants With HBeAg Seroconversion on ETV Over-time at Week 96 (All ETV Cohort)(At Week 96)
- Percentage of Participants With HBeAg Seroconversion (Undetectable HBeAg and Presence of Anti-HBeAb) up to Week 96(up to week 96)
- Percentage of Participants With HbeAg Loss at Weeks 48 and 96(At 48 and 96 weeks)