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

临床试验：第 3 阶段双盲、随机、安慰剂对照研究

• 批准号: 8167313
• 负责人: PARVATHI MOHAN
• 金额: $ 0.2万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-20 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167313
• 关键词: Adolescent; Adverse effects; Age; Child; Chronic Hepatitis B; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Development; Diarrhea; Dizziness; Dose; Double-Blind Method; Funding; Gases; Grant; Growth; Headache; Hepatitis B Surface Antigens; Hepatitis B Virus; Hepatitis B e Antigens; Institution; Liver diseases; Nausea; Pain; Patients; Phase; Placebos; Population; Renal function; Research; Research Personnel; Resistance; Resources; Safety; Source; Stomach; United States National Institutes of Health; Visit; adefovir dipivoxil; experience; follow-up; mutant; nephrotoxicity; randomized placebo controlled trial

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是探讨阿德福韦酯治疗以下疾病的有效性和安全性： 与安慰剂相比，儿童和青少年（2 至 18 岁）慢性乙型肝炎的治疗 治疗 48 周后；评估儿童和青少年的比例 使用阿德福韦治疗 48 周后经历 HBeAg 和 HBsAg 血清转换 地吡沃西或安慰剂；评估对阿德福韦酯耐药的 HBV 突变体的发展； 评估儿童和青少年超过 4 年的长期安全性和有效性 一年的随访期包括生长和肾功能的评估。共同的一面 影响包括虚弱、头痛、胃痛、恶心、胀气、腹泻和胃部不适。 一些患有晚期慢性乙型肝炎肝病和肾功能受损的患者， 服用阿德福韦酯 10 mg 引起肾毒性。在儿童中，有头痛和 头晕一般较轻微，且似乎与剂量无关。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 将地吡沃西治疗组与安慰剂治疗组在所有方面进行比较 功效终点。 这些分析将使用意向治疗 (ITT) 人群。这 将对意向治疗人群进行初​​步分析。