EUCTR2011-002732-70-BG进行中（未招募）1 期
A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children with HBeAg Positive Chronic Hepatitis B in the Immune Active Phase.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 161
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
- •Children aged 3 to <18 years of age with CHB, HBeAg+ve, HBsAg+ve, detectable HBV DNA (>10,000 copies/mL [>2,000 IU/ml]) by PCR and ALT >ULN but =10 x ULN (using the local sites’ reference range). Liver biopsy needs to have been conducted within the previous 2 years.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 160
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects co-infected with HCV, HDV, HIV, or who have received therapy for hepatitis B in the prior 6 months, or have cirrhosis, or who have de-compensated liver disease will be excluded.
研究者
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