CLINICAL TRIAL: A PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 本研究的目的是观察阿德福韦酯治疗慢性阻塞性肺疾病的疗效和安全性。 儿童和青少年(2-18岁)慢性乙型肝炎的治疗与安慰剂的比较 在治疗48周后；评估儿童和青少年中 阿德福韦治疗48周后HBeAg和HBs Ag血清转换的体会 评估对阿德福韦酯耐药的乙肝病毒突变株的发展； 对儿童和青少年的长期安全性和有效性进行评估 一年的随访期，包括生长发育和肾功能评估。共同的一面 其影响是虚弱、头痛、胃痛、恶心、放气、腹泻和胃部不适。 部分慢性乙型病毒性肝炎晚期患者肾功能受损， 服用阿德福韦酯10 mg可引起肾毒性。在儿童中，头痛和头痛的顺应性 头晕通常是轻微的，而且似乎与剂量无关。主端点 分析将在所有患者达到48周的研究访问时进行。阿德福韦 治疗组与安慰剂治疗组在以下方面进行比较 功效终点。意向治疗(ITT)人群将用于这些分析。这个 将对意向治疗人群进行初步分析。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to 18) compared to placebo following 48 weeks of treatment; To evaluate the proportion of children and adolescents who experience HBeAg and HBsAg seroconversion following 48 weeks of treatment with adefovir dipivoxil or placebo; To evaluate the development of HBV mutants resistant to adefovir dipivoxil; To evaluate the long-term safety and efficacy in children and adolescents over an additional 4 year follow up period including assessment of growth and renal function. The common side effects were weakness, headache, stomach pain, nausea, gas, diarrhea, and upset stomach. some patients with advanced chronic hepatitis B liver disease and impaired kidney function, taking adefovir dipivoxil 10 mg caused nephrotoxicity. In children, complants of headache and dizziness were generally mild, and did not appear to be related to dose. The primary endpoint analysis will be performed when all patients reach the week 48 study visit. The adefovir dipivoxil treatment group will be compared to the placebo treatment group with respect to all efficacy endpoints. The intent to treat (ITT) population will be used for these analyses. The primary analysis will be performed on the intent-to-treat population.