Baltic Post-marketing Program of PEGASYS (Peg Interferon 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
- 39
- 主要终点
- Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
研究概览
简要总结
This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of 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 less than 100 participants.
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 participants, 18-70 years of age;
- •HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
- •anti-HBs negative;
- •Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.
排除标准
- •Previous antiviral or interferon-based therapy for chronic hepatitis B;
- •Evidence of decompensated liver disease;
- •Chronic liver disease other than viral hepatitis;
- •Co-infection with active hepatitis A, C or D virus;
- •Co-infection with human immunodeficiency virus.
研究组 & 干预措施
Peginterferon Alfa-2a
Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
时间窗: Week 72
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (\>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels \< 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
时间窗: Week 72
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA \>10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA \<10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.
次要结局
- Number of Participants With HBV-DNA < 400 Copies/mL(Week 72)
- Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants(Week 48 and Week 72)
- Percentage of Anti-HBs Positive Participants(Week 48 and Week 72)
- Mean Alanine Aminotransferase (ALT) Concentrations(Week 48 and Week 72)
- Percentage of HBeAg Negative Participants(Week 48 and Week 72)
- Percentage of Anti-HBe Positive Participants(Week 48 and Week 72)