EUCTR2011-002812-10-DE进行中（未招募）1 期
A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated Interferon alfa-2a (Pegasys®) 180 µg once weekly for 48 weeks in addition to an ongoing nucelos(t)ide based treatment on quantitative HBsAg levels in patients with chronic HBeAg-negative hepatitis B - PADD-O
niversity Medical Center of the Johannes Gutenberg University Mainz0 个研究点开始时间: 2011年11月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Chronic hepatitis B, HBe antigen negative
- •Treatment with a stable oral antiviral treatment (not containing telbivudine) and a fully suppressed viral load for at least 12 months (below limit of detection in conventional HBV-PCR assays, i.e. <116 IU / ml).
- •18-70 yrs
- •Willingness and ability to give informed consent and to follow study procedures
- •willingness to use adequate contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 153
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •HBe antigen positive Hepatitis B
- •Co-infection with HCV, HDV or HIV – as based on positive serology or PCR
- •Ongoing antiviral treatment with Telbivudine
- •Contraindications against treatment with pegylated interferon, e.g. severe depression, epilepsy, autoimmune diseases, pregnancy, leukocytopenia or thrombocytopenia at screening, etc.
- •Preexisting polyneuropathy
研究者
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