An Open-label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 671
- 主要终点
- Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.
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
- 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
- •Adults with chronic hepatitis B:
- •Serum hepatitis B surface antigen positive for at least 6 months
- •Serum hepatitis B e antigen positive
- •Serum negative for hepatitis B surface and e antibodies
- •Plasma hepatitis B virus deoxyribonucleic acid (DNA) level greater than 20,000 IU/mL
- •Alanine aminotransferase (ALT) 2- to 10-times the upper limit of normal
- •Compensated liver disease with certain minimum hematological and serum biochemical criteria
排除标准
- •Significant hepatic disease from an etiology other than hepatitis B virus
- •Antiviral treatment for hepatitis within previous 6 months
- •History of severe psychiatric disease, especially depression
- •Unstable or significant cardiovascular disease
- •Prolonged exposure to known hepatotoxins such as alcohol or drugs
- •Any condition that could interfere with the subject participating in and completing the study
研究组 & 干预措施
PEG 1.0 mcg/kg weekly (QW) * 24 weeks
PegIntron 1.0 mcg/kg weekly (QW) * 24 weeks + 24 weeks follow-up
干预措施: pegylated interferon alpha-2b (Drug)
PEG 1.5 mcg/kg QW * 24 wks
PegIntron 1.5 mcg/kg QW * 24 wks + 24 wks follow-up
干预措施: pegylated interferon alpha-2b (Drug)
PEG 1.5 mcg/kg QW * 48 wks
PegIntron 1.5 mcg/kg QW * 48 wks + 24 wks follow-up
干预措施: pegylated interferon alpha-2b (Drug)
结局指标
主要结局
Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
时间窗: 24 weeks after end of treatment (EOT)
HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)
次要结局
- Number of Participants With Combined Response(End of treatment (EOT) and 24 weeks after EOT)
- Number of Participants With HBeAg Loss(Up to Treatment Week 48)
- Number of Participants With HBV-DNA Undetectable(End of treatment (EOT) and 24 weeks after EOT)
- Hepatitis B Surface Antigen (HBs) Seroconversion(End of treatment (EOT) and 24 weeks after EOT)
- HBe Seroconversion(End of treatment (EOT) and 24 weeks after EOT)
- Change From Baseline in Liver Biopsy Score(Baseline to 24 weeks after end of treatment)
- Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL(End of treatment (EOT) and 24 weeks after EOT)
- Number of Participants With HBV-DNA < 200 IU/mL(End of treatment (EOT) and 24 weeks after EOT)
- Hepatitis B Surface Antigen (HBsAg) Loss(End of treatment (EOT) and 24 weeks after EOT)
- Number of Participants With Biochemical Response(End of treatment (EOT) and 24 weeks after EOT)