Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (Pegasys®) 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
- 307
- 主要终点
- Percentage of participants with HBeAg seroconversion
研究概览
简要总结
This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period 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
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants between 18 to 65 years of age
- •HBeAg-positive chronic HBV
- •Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.
排除标准
- •Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
- •Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
- •Evidence of decompensated liver disease
- •Medical condition associated with chronic liver disease other than viral hepatitis.
研究组 & 干预措施
Group A (Naïve Participants)
Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms [mcg]) subcutaneously once weekly for 48 weeks.
干预措施: Peginterferon alfa-2a (Drug)
Group B (Conventional Interferon Pretreated Participants)
Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
干预措施: Peginterferon alfa-2a (Drug)
Group C (Lamivudine Pretreated Participants)
Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
Percentage of participants with HBeAg seroconversion
时间窗: 72 weeks
Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL)
时间窗: 72 weeks
次要结局
- Number of participants who achieved HBV DNA levels below limit of detection(Weeks 48 and 72)
- Number of participants with HBsAg loss(Weeks 48 and 72)
- Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs(Weeks 48 and 72)
- Number of participants with alanine aminotransferase (ALT) normalization(Weeks 48 and 72)
- Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization)(Weeks 48 and 72)
- Incidence of adverse events(up to 72 weeks)