NCT00962975已完成1 期
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA
研究概览
简要总结
In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is <100.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients >/=18 years of age
- •previous participation in other donor protocol
- •chronic hepatitis B
- •no other anti-HBV treatment after completion of previous donor protocol
- •female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study
排除标准
- •hepatic decompensation (Child-Pugh class B and C)
- •antiviral, antineoplastic or immunomodulatory treatment
- •evidence of alcohol and/or drug abuse
研究组 & 干预措施
Single Arm
Experimental
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA
时间窗: assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up
次要结局
- Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications(assessed every 2 months on treatment and up to week 24 of follow-up)
研究者
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