JPRN-jRCTs051180151已完成2 期
Evaluation of the efficacy of combination therapy with entecavir and pegylated interferon in children with Hepatitis B Virus infection
Tajiri Hitoshi0 个研究点目标入组 2 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
Combination therapy of entecavir and peginterferon was safe but not effective in the two cases.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 3age 至 18age(—)
- 性别
- All
入选标准
- •1. Patient age is greater than 3 years of age and less than 18 years of age at the time of obtaining informed consent.
- •2. sustained elevation in ALT (greater than 60 IU/l) for more than six months.
- •3. Patients with HBeAg positive or negative.
- •4. HBVDNA titer greater than 4.0 log copies /ml
- •5. Fibrosis stage F2-3 or Hepatitis activity grade A2-3 according to the New Inuyama classification.
- •6. Written informed consent after adequate explanation and acceptance.
排除标准
- •1. Patients with a suspicion of liver cirrhosis by blood examination or imaging studies.
- •2. Patients who is diagnosed as liver cirrhosis by pathological examination.
- •3. Patients with hepatocellular carcinoma.
- •4. Patients with poor adherence of medicine.
- •5. Patients who have any underlying disorders which can be affected by the treatment.
- •6. Patients who are assessed to be ineligible for this study by the principle investigator.
研究者
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