NCT01088659已完成3 期
A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- proportion of patients becoming HDV-RNA negative
研究概览
简要总结
This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is <50.
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
- Double (Participant, Investigator)
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
- •chronic hepatitis D
- •positive for HBsAg >/=6 months, for anti-HDV >/=3 months and for HDV-RNA at screening
- •negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study
排除标准
- •antiviral therapy for chronic hepatitis D within the previous 6 months
- •previous therapy with pegylated interferon alfa
- •treatment with conventional interferon alfa for >12 months
- •hepatitis A or C, or HIV infection
- •decompensated liver disease (Childs B-C)
- •history or evidence of medical condition associated with chronic liver disease
研究组 & 干预措施
1
Experimental
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
1
Experimental
干预措施: placebo (Drug)
2
Experimental
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
2
Experimental
干预措施: tenofovir (Drug)
结局指标
主要结局
proportion of patients becoming HDV-RNA negative
时间窗: week 96
次要结局
- HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology(weeks 48, 96 and after 24 weeks of follow-up)
- Safety and tolerability: adverse events, laboratory parameters, vital signs(throughout 96 weeks of treatment)
研究者
研究点 (6)
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