NCT02570191已完成4 期
An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 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 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
- •Positive test result for HBsAg for >6 months
- •Naive to treatment for HBV
- •On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis
排除标准
- •Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
- •Decompensated liver disease
- •Hepatocellular cancer
- •Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
- •Medical condition associated with chronic liver disease
研究组 & 干预措施
Peginterferon alfa-2a
Experimental
Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter [mL] solution) once a week subcutaneously for 48 weeks.
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up
时间窗: 72 Weeks
Alanine Transaminase (ALT) Normalization at the End of Follow-Up
时间窗: 72 Weeks
次要结局
- Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up(72 Weeks)
- Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up(72 Weeks)
- HBV DNA Suppression <20000 Copies/mL at the End of Treatment(48 Weeks)
- Alanine Transaminase (ALT) Normalization at the End of Treatment(48 Weeks)
研究者
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