PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL
研究概览
简要总结
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-70 years of age;
- •chronic hepatitis B;
- •Hepatitis B Virus (HBV) DNA >100,000 copies/mL.
排除标准
- •previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
- •evidence of decompensated liver disease;
- •history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
- •coinfection with hepatitis A, C or D, or HIV.
研究组 & 干预措施
Peginterferon Alfa-2a
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL
时间窗: Week 96
This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) \<100,000 copies/mL were reported.
Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL
时间窗: Week 96
This study included 14 HBeAg negative participants. Participants with HBV DNA \<20,000 copies/mL were reported.
次要结局
- Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT(Week 96)
- Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)(Up to Week 96)
- Mean Change in Laboratory Parameters (ALT Levels)(From Screening (Day 0) to Week 96)
- Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion(Week 96)