EUCTR2006-000977-31-BE进行中（未招募）1 期
PHASE IIIB, RANDOMIZED, OPEN LABEL STUDY OF PEGYLATED INTERFERON ALFA-2A IN COMBINATION WITH LAMIVUDINE OR ENTECAVIR COMPARED WITH UNTREATED CONTROL PATIENTS IN CHILDREN WITH HBEAG POSITIVE CHRONIC HEPATITIS B IN THE IMMUNE TOLERANT PHASE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 59
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
- •Male and female patients 3 to less than 18 years of age at baseline (12< 18 years of age at baseline in Russia and India)
- •Positive for HBsAg and HBeAg for more than 6 months prior to baseline
- •Detectable HBV-DNA (> 20,000 IU/mL as measured by PCR or hybridization) on at least 2 occasions at least one month apart with the latest determination obtained = 42 days prior to baseline.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 114
- •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
- •Patients who have had any previous anti-HBV treatment, or who are co-infected with hepatitis A virus (HAV), HCV, hepatitis D virus (HDV) or HIV, or who have decompensated liver disease will beexcluded.
研究者
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