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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是观察阿德福韦酯治疗慢性乙型肝炎的疗效和安全性。 儿童和青少年（2 - 18岁）慢性B型肝炎治疗与安慰剂相比 治疗48周后;评估儿童和青少年中 阿德福韦治疗48周后发生HBeAg和HBsAg血清转换 评价对阿德福韦酯耐药的HBV突变株的发展; 在儿童和青少年中评价额外4年的长期安全性和疗效 1年随访期，包括生长和肾功能评估。公共侧 影响是虚弱、头痛、胃痛、恶心、胀气、腹泻和胃部不适。 部分慢性B型肝炎晚期肝病和肾功能受损患者， 服用阿德福韦酯10 mg引起肾毒性。在儿童中，头痛和 头晕通常为轻度，似乎与剂量无关。主要终点 当所有患者达到第48周研究访视时，将进行分析。 阿德福韦 将地尔宁治疗组与安慰剂治疗组在所有方面进行比较， 疗效终点。 这些分析将使用意向治疗（ITT）人群。的 将对意向治疗人群进行主要分析。

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.