NCT02822547Unknown4 期
Study to Identify Eligible Subjects Using Response Guided Therapy-Stopping Rule for Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B
研究概览
简要总结
Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of HBsAg positive for more than 6 months
- •HBeAg-positive or HBeAg-negative within 8 weeks
- •Serum AST or ALT ≥ 80 IU/L
- •HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10^5 copies/mL (or 20,000 IU/mL)
- •HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10^4 copies/mL(or 2,000 IU/mL)
排除标准
- •History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment
- •Prior treatment of interferon
- •Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus)
- •Other chronic liver disease or decompensated liver disease
- •platelet<90,000/mm3 or absolute neutrophil count < 1,500 mm3
- •Pregnant or lactating woman
- •History of Organ transplantation
- •Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry
研究组 & 干预措施
Peginterferon alfa-2a
Experimental
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
The proportion subjects with HBsAg ≤ 20,000 IU/mL at 12 week treatment of PEG-IFN in HBeAg-positive Chronic Hepatitis B
时间窗: 12 week from baseline
The proportion subjects with any decline of HBsAg and/or HBV DNA decline more than 2 log copies/ml at 12 week treatment of PEG-IFN in HBeAg-negative CHB
时间窗: 12 week from baseline
次要结局
- The proportion of HBV DNA undetectable level (< 60 IU/mL, approximately 300 copies/mL) at week 12(12 week from baseline)
- The change of HBsAg at Week 4, 8, 12 from baseline(4, 8, 12 week from baseline)
- The change of HBV DNA at Week 12 from baseline(12 week from baseline)
- The change of ALT at week 4, 8, 12 from baseline(4, 8, 12 week from baseline)
研究者
研究点 (1)
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