A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
研究概览
简要总结
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
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
- Double (Participant, Investigator)
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
- •adult patients, 18-65 years of age;
- •HBeAg+ve for >=3 months;
- •positive serum HBV DNA within 3 months prior to entry;
- •patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
- •>=3 months treatment-free interval from nucleotide analogues.
排除标准
- •evidence of decompensated liver disease;
- •history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
- •co-infection with active hepatitis A,C or D, or HIV.
研究组 & 干预措施
2
干预措施: Entecavir (Drug)
1
干预措施: Adefovir (Drug)
1
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
2
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
3
干预措施: Placebo (Drug)
3
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
时间窗: Week 100
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
次要结局
- Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive(Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100)
- Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100(Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100)
- Percentage of Participants Who Were HBeAg Negative(Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100)
- Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100(Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100)
- Percentage of Participants With Combined Response(Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100)
- Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels(Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100)