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放牛哥哥

群共享里上传了《慢性乙型肝炎病毒感染处理治疗规范》，现在这里也传一个。
通过学习《规范》，可以了解自己身体到底处在啥状态，现在该如何应对！

放牛哥哥

解压后用acrobat reader打开即可阅读！

liaoyanhui

顶一下!!

放牛哥哥

http://translate.google.cn/translate?hl=zh-CN&langpair=en|zh-CN&u=http://clinicaltrials.gov/ct2/show/NCT00371761&prev=/translate_s%3Fhl%3Dzh-CN%26q%3DPEGINTRON%25C2%25AE%2BTreatment%2Bfor%2BHepatitis%2BB%26sl%3Dzh-CN%26tl%3Den
聚乙二醇干扰素与阿德福韦治疗慢性乙型肝炎（ CHB ） e抗原阳性患者在台湾（研究P04498 ）
This study is ongoing, but not recruiting participants.这项研究正在进行之中，但不招募参加者。
First Received: August 31, 2006  Last Updated: March 20, 2009 History of Changes第一收稿： 2006年8月31日最后更新日期： 2009年3月20号的历史变迁
Sponsored by:主办单位：  Schering-Plough 先灵葆雅

Information provided by:所提供的资料：  Schering-Plough先灵葆雅  
ClinicalTrials.gov Identifier: ClinicalTrials.gov标识符：  NCT00371761 NCT00371761  

Purpose 目的
This is an open label, randomized, comparative, multi-center study.这是一个开放的标签，随机，对照，多中心研究。 Subjects will be screened within 2 weeks prior to study entry to establish eligibility.科目将放映前2周内，研究确定进入资格。 Subjects who meet all the selection criteria will be randomly assigned 1:1 to (1) once-a-week, subcutaneous Peg-Intron (1.5 mg/kg body weight) or (2) oral adefovir 10 mg daily.谁满足所有科目的选择标准将被随机分配1:1 （ 1 ）一次的一周，皮下长效干扰素（ 1.5毫克/千克体重）或（ 2 ）口服阿德福韦每日10毫克。 The treatment phase will be 24 weeks for Peg-Intron and 48 weeks for adefovir.治疗阶段将在24周了PEG -干扰素和48周的阿德福韦。 All subjects completing the assigned treatment phase will be followed up for an additional 48 weeks for Peg-Intron and 24 weeks for adefovir as observation phase.所有受试者均完成了分配的治疗阶段将随访48周增加了PEG -干扰素和24周的阿德福韦作为观察阶段。 The primary objective is to establish the efficacy profile of Peg-Intron.其主要目标是建立效能档案聚乙二醇干扰素。 Secondary objectives are to compare the efficacy profile of Peg-Intron with that of adefovir, compare efficacy of Peg-Intron in lamivudine-naïve and lamivudine-experienced subjects, and to establish the safety profile of Peg-Intron in treating patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.次要目标是比较形象的功效的PEG -干扰素与阿德福韦，比较疗效聚乙二醇内含拉米夫定天真和拉米夫定经验学科，并建立了安全性的PEG -干扰素治疗乙型肝炎e抗原（ e抗原）阳性的慢性乙型肝炎



Condition 条件  Intervention 干预  Phase 相  
Hepatitis B, Chronic肝炎，乙型，慢性
Drug: Pegylated interferon alfa-2b药物：聚乙二醇干扰素α - 2b
Drug: Adefovir dipivoxil药物：阿德福韦酯
Phase III第三阶段




MedlinePlus related topics: Hepatitis Hepatitis B MedlinePlus相关主题： 肝炎 乙型肝炎
Drug Information available for: Interferon alfa-2a Interferon alfa-2b Adefovir Adefovir dipivoxil Peginterferon Alfa-2b Interferon alfa-n1 Hepatitis B Vaccines Interferons 药品信息提供： 干扰素α - 2A型 干扰素α - 2b 阿德福韦酯 阿德福韦酯 聚乙二醇化α - 2b 干扰素 干扰素α -的N1 乙型肝炎疫苗 干扰素
US FDA Resources 美国 FDA 资源
Study Type:研究类型：  Interventional介入  
Study Design:研究设计：  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study治疗中心，随机，开放标签，主动控制，并行作业，功效研究  
Official Title:正式名称：  An Open-Label, Randomized, Comparative Study With Peg-Intron vs. Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan一个开放性，随机，对照研究，长效干扰素与阿德福韦治疗慢性乙型肝炎（ CHB ） e抗原阳性患者在台湾  


Further study details as provided by Schering-Plough:进一步的研究提供了详细先灵葆雅：


Primary Outcome Measures:主要观察指标：
Combined response consisting of (a) serological response (loss of HBeAg and appearance of anti-HBe), (b) virological response (HBV DNA <105 copies/mL by real-time PCR), (c) biochemical response (normalization of serum ALT level) [ Time Frame: At Week 72 (for Group A, at 48 weeks post Peg-Intron treatment for up to 24 weeks; for Group B, at 24 weeks post adefovir treatment for up to 48 weeks) ] [ Designated as safety issue: No ]结合反应包括： （ a ）血清学应答（ HBeAg和损失出现抗- HBe ） ， （二）病毒学应答（ HBV DNA的“ 105拷贝/毫升的实时PCR ） ， （三）生化反应（血清正常化转氨酶水平） [期限： 72周（ A组，在48周后长效干扰素治疗时间最长为24周， B组，在24周后阿德福韦治疗长达48周） ] [指定为安全问题：否]



Secondary Outcome Measures:二级指标：
(a) Combined response; (b) The rates of serologic response,serum HBV DNA <105 copies/mL,HBeAg loss, ALT normalization, HBsAg loss; (c) The rate of histologic response [ Time Frame: (a) At the end of treatment (Group A at 24 weeks, Group B at 48 week); (b) At the end of treatment and at Week 72; (c) At Week 72 ] [ Designated as safety issue: No ] （ a ）联合反应; （ b ）在利率血清反应，血清HBV DNA “ 105拷贝/毫升， HBeAg的损失， ALT正常化， HBsAg的损失; （三）组织学反应率[时间框架： （ a ）在治疗结束时（ A组在24周， B组为48周） ; （ b ）在治疗结束时和72周; （ c ）在周72 ] [指定的安全问题：否]


Estimated Enrollment:估计报名：  160 160  
Study Start Date:研究开始日期：  March 2006 2006年3月  
Estimated Study Completion Date:研究估计完工日期：  February 2009 2009年2月  
Estimated Primary Completion Date:初步估计完工日期：  February 2009 (Final data collection date for primary outcome measure) 2009年2月（最后数据收集日期为主要成果衡量）  

Arms 武器  Assigned Interventions 分配干预  
Group A: Experimental A组：实验
Peg-Intron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase聚乙二醇干扰素， 1.5微克/千克每周长达24周之后， 48周的观察阶段  Drug: Pegylated interferon alfa-2b药物：聚乙二醇干扰素α - 2b
Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks粉针剂在小瓶（ 100 ，和120微克的优势） ，皮下注射，剂量为1.5微克/千克，每周不超过24周  
Group B: Active Comparator B组：主动比较
Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase阿德福韦，每天10毫克，最多48周之后， 24周的观察阶段  Drug: Adefovir dipivoxil药物：阿德福韦酯
10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks阿德福韦酯10毫克（相当于5.4.5毫克阿德福韦）片剂，口服液，剂量为1片，每天最多48周  



Eligibility 资格


Ages Eligible for Study:年龄符合条件的研究：  18 Years to 70 Years 18岁至70岁  
Genders Eligible for Study:男女合资格的研究：  Both两者  
Accepts Healthy Volunteers:接受健康志愿者：  No否  

Criteria标准
Inclusion Criteria:纳入标准：

放牛哥哥

Adult male or female, 18 to 70 years of age.成年男性或女性， 18至70岁。
Documented positive serum hepatitis B surface antigen (HBsAg) for a minimum of 6 months prior to randomization.记录阳性血清乙型肝炎表面抗原（ HBsAg的）至少6个月前随机。
Hepatitis B virus (HBV) replication and hepatitis documented by:乙型肝炎病毒（ HBV ）复制和肝炎记录：

Serum HBV DNA >= 105 copies/mL within 3 months prior to entry血清HBV DNA “ = 105拷贝/毫升3个月内，入境前
Positive serum hepatitis B e antigen (HBeAg) within 3 months prior to entry阳性血清乙型肝炎e抗原（ HBeAg的） 3个月内，入境前
Documented presence of ALT twice (1 month apart) within 3 months prior to entry (2 to 10 folds above the upper normal level)记录存在转氨酶两次（ 1月除） 3个月内，入境前（ 2至10倍以上的正常水平上）
Liver biopsy finding shows evidence of chronic hepatitis without liver cirrhosis, document acceptable if no anti-HBV treatment within 1 year prior to randomization肝活检发现有证据表明慢性肝炎没有肝硬化，可以接受的文件，如果没有抗乙肝病毒治疗一年前随机
Naïve or exposed to lamivudine (3 months treatment-free interval prior to randomization)天真或接触拉米夫定（ 3个月的治疗无间隔之前随机）
Adequate renal function (creatinine within normal upper limit).足够的肾功能（肌酐在正常上限） 。
Compensated liver disease with certain minimum hematological and serum biochemical criteria.补偿肝病与某些最低限度的血液和血清生化标准。
Thyroid stimulating hormone (TSH) and free T4 within normal ranges.促甲状腺激素（激素）和游离T4在正常范围内。
Negative antibody to hepatitis C and hepatitis D.抗体阴性丙型肝炎病毒和肝炎4
Negative antibody to human immunodeficiency virus.抗体阴性，以人类免疫缺陷病毒。
Negative evidence for hepatocellular carcinoma by alfa-fetoprotein and ultrasound within 1 month prior to randomization.负面证据阿尔法肝癌甲胎蛋白和超声之前1个月内，向随机。
Exclusion Criteria:排除标准：

Women who are pregnant or nursing.谁是妇女怀孕或哺乳。
Prior treatment for hepatitis with any interferon or adefovir, or other investigational anti-virus agents.事先治疗肝炎的任何干扰素或阿德福韦，或其他研究的抗病毒制剂。
Prior treatment for hepatitis with immunomodulatory drug within 2 years prior to randomization.事先治疗肝炎的免疫调节药物在2年前随机。
Suspected hypersensitivity to interferon or adefovir.怀疑过敏干扰素或阿德福韦。
Liver cirrhosis.肝硬化。
History of severe psychiatric disease, especially depression.历史上严重的精神疾病，尤其是抑郁症。
Concurrent malignancies (including hepatocellular carcinoma).并发恶性肿瘤（包括肝癌） 。
Unstable or significant cardiovascular diseases.不稳定或重要的心血管疾病。
Prolonged exposure to known hepatotoxins.长期暴露于已知hepatotoxins 。
History of thyroid disease poorly controlled on prescribed medication.历史上的甲状腺疾病的控制不良处方药物。
Poorly controlled diabetes mellitus.糖尿病控制不良。
Have suspected or confirmed significant hepatic disease from an etiology other than HBV.有怀疑或证实重大肝病从病因以外乙型肝炎。
Severe renal disease or myeloid dysfunction.严重肾功能障碍的疾病或髓。
History of organ transplantation other than cornea and hair transplant.史以外的其他器官移植角膜和头发移植手术。
Any medical condition requiring chronic systemic administration of steroids.任何医疗条件，如规定慢性系统性管理类固醇。
Contacts and Locations 联系人和地点

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371761请参阅本研究其ClinicalTrials.gov标识符： NCT00371761


Locations地点
Taiwan台湾  
Investigational Site 1侦查网站1  
Taipei, Taiwan, 100台湾台北， 100  
Investigational Site 2侦查网站2  
Taipei, Taiwan, 114台湾台北， 114  
Investigational Site 3侦查网站3  
Taiwan, Taiwan, 333台湾，台湾， 333  
Investigational Site 6侦查网站6  
Tainan, Taiwan, 704台南，台湾， 704  
Investigational Site 5侦查网站5  
Taichung, Taiwan, 404台湾台中县， 404  
Investigational Site 4侦查网站4  
Changhua, Taiwan, 500台湾彰化500  

Sponsors and Collaborators赞助商和合作者
Schering-Plough 先灵葆雅
More Information 更多信息

No publications provided任何出版物提供

Responsible Party:责任方：  Schering-Plough ( Bryan Wahking, MD - Medical Director, Taiwan Country Operations )先灵葆雅（布赖恩Wahking ，医学博士-医务主任，台湾国家行动）  
Study ID Numbers:研究身份证号码：  P04498 P04498  
Study First Received:研究首先收到：  August 31, 2006 2006年8月31日  
Last Updated:最后更新：  March 20, 2009 2009年3月20号  
ClinicalTrials.gov Identifier: ClinicalTrials.gov标识符：  NCT00371761 History of Changes NCT00371761 的历史变迁  
Health Authority:卫生局：  Taiwan: Department of Health台湾：卫生署  

Keywords provided by Schering-Plough:关键词提供先灵葆雅：
Hepatitis B virus乙型肝炎病毒
Interferon Alfa-2b干扰素α - 2b



Study placed in the following topic categories:研究放在以下专题分类：
Interferon-alpha α -干扰素
Liver Diseases肝脏疾病
Hepatitis, Chronic肝炎，慢性
Interferons干扰素
Hepatitis, Viral, Human肝炎，病毒性，人
Angiogenesis Inhibitors血管生成抑制剂
Antiviral Agents抗病毒药物
Reverse Transcriptase Inhibitors逆转录酶抑制剂
Hepatitis肝炎
Virus Diseases病毒病
Digestive System Diseases消化系统疾病
Anti-Retroviral Agents抗逆转录病毒药物
Hepatitis B, Chronic肝炎，乙型，慢性
Hepatitis B乙型肝炎
Peginterferon alfa-2b聚乙二醇化α - 2b干扰素
Adefovir dipivoxil阿德福韦酯
DNA Virus Infections DNA病毒感染
Interferon Alfa-2a干扰素α - 2A型
Adefovir阿德福韦
Interferon Alfa-2b干扰素α - 2b



Additional relevant MeSH terms:相关主题词附加条款：
Anti-Infective Agents抗感染药
Liver Diseases肝脏疾病
Molecular Mechanisms of Pharmacological Action分子药理作用机制
Hepatitis, Chronic肝炎，慢性
Immunologic Factors免疫因素
Antineoplastic Agents抗肿瘤药
Physiological Effects of Drugs毒品的生理影响
Hepatitis, Viral, Human肝炎，病毒性，人
Hepadnaviridae Infections Hepadnaviridae感染
Reverse Transcriptase Inhibitors逆转录酶抑制剂
Anti-Retroviral Agents抗逆转录病毒药物
Hepatitis B, Chronic肝炎，乙型，慢性
Therapeutic Uses治疗用途
Hepatitis B乙型肝炎
Growth Inhibitors生长抑制剂
Angiogenesis Modulating Agents血管生成调节剂
Nucleic Acid Synthesis Inhibitors核酸合成抑制剂
Interferon-alpha α -干扰素
Growth Substances生长物质
Interferons干扰素
Enzyme Inhibitors酶抑制剂
Antiviral Agents抗病毒药物
Angiogenesis Inhibitors血管生成抑制剂
Pharmacologic Actions药理行动
Virus Diseases病毒病
Hepatitis肝炎
Digestive System Diseases消化系统疾病
Peginterferon alfa-2b聚乙二醇化α - 2b干扰素
DNA Virus Infections DNA病毒感染
Adefovir dipivoxil阿德福韦酯



ClinicalTrials.gov processed this record on April 06, 2009 ClinicalTrials.gov处理这一纪录2009年4月6日


Back to top of Main Content 回到顶部主要内容

放牛哥哥

上面这段是在台湾做的一个临床研究（佩乐能单药PK佩乐能+阿德），供药阶段已经完成，停药后的随访结论即将给出。
链接处有一个子页面是给result的，期待结论。

放牛哥哥

下面这段357---358楼，是在中国做的一个多中心临床研究（佩乐能单药剂量和周期对疗效的影响），供药阶段基本完成，停药后的随访结论将在今年10月出。
链接处有一个子页面是给result的，期待结论。

[ 本帖最后由 佩乐能 于 2009-4-8 13:35 编辑 ]

放牛哥哥

http://translate.google.cn/translate?hl=zh-CN&langpair=en|zh-CN&u=http://clinicaltrials.gov/ct2/show/NCT00536263&prev=/translate_s%3Fhl%3Dzh-CN%26q%3DPEGINTRON%25C2%25AE%2BTreatment%2Bfor%2BHepatitis%2BB%26sl%3Dzh-CN%26tl%3Den

跟踪信息  
First Received Date †首先收稿日期†  September 26, 2007 2007年9月26日  
Last Updated Date最后更新日期：  April 2, 2009 2009年4月2日  
Start Date †开始日期†  September 2007 2007年9月  
Current Primary Outcome Measures †当前的主要成果措施†
January 3, 2008 2008年1月3日  HBeAg Loss [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ] HBeAg的损失[时限： 24周后治疗结束] [指定的安全问题：否]  
Original Primary Outcome Measures †原来的主要成果措施†  Same as current同目前的  
Change History更改历史记录  Complete list of historical versions of study NCT00536263 on ClinicalTrials.gov Archive Site 完整的历史版本的研究NCT00536263对ClinicalTrials.gov archive站台  
Current Secondary Outcome Measures †目前的中学成果措施†
January 3, 2008 2008年1月3日  HBe seroconversion [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ] e抗体阳转[时限：治疗结束时和结束后24周的治疗] [指定的安全问题：否]
HBV-DNA decrease [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]乙型肝炎病毒DNA减少[时限：治疗结束时和结束后24周的治疗] [指定的安全问题：否]
ALT normalization [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ] ALT正常化[时限：治疗结束时和结束后24周的治疗] [指定的安全问题：否]
Combined Response (defined as HBV DNA (PCR) <20,000 IUs/ml and HBe seroconversion and ALT normalization) [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ]综合反应（定义为乙型肝炎病毒DNA （ PCR ）技术“ 20000学联/ ml和e抗体和血清ALT正常化） [期限：治疗结束时和结束后24周的治疗] [指定的安全问题：否]
HBsAg Loss [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ] HBsAg的损失[时限：治疗结束时和结束后24周的治疗] [指定的安全问题：否]
HBs seroconversion [ Time Frame: End of treatment and 24 weeks after end of treatment ] [ Designated as safety issue: No ] HBs阳性血清[时限：治疗结束时和结束后24周的治疗] [指定的安全问题：否]

Original Secondary Outcome Measures †原始次生成果措施†  Same as current同目前的  

Descriptive Information描述性信息  
Brief Title †简短的标题†  PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (Study P05170) PegIntron治疗慢性乙型肝炎e抗原阳性患者（研究P05170 ）  
Official Title †正式名称†  An Open-Label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients一个开放性，随机研究PegIntron治疗HBeAg阳性慢性乙型肝炎患者  
Brief Summary简要介绍  The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating e antigen-positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks.本研究的目的是确定的疗效和安全性两个剂量PegIntron治疗e抗原阳性慢性乙型肝炎与核准的用量，这是PegIntron 1.0微克（微克） /千克给予每周一次为24周。 This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage.这项研究比较剂量（ 1 ） 1.5毫克/千克每星期一次的24周和第（ 2 ） 1.5毫克/千克每星期一次的48周与核定剂量。 All subjects are followed for 24 weeks after their treatment ends.所有科目都遵循的24周后，治疗的目的。

Detailed Description详细说明   
Study Phase研究阶段  Phase III第三阶段  
Study Type †学习型†  Interventional介入  
Study Design †研究设计†  Treatment, Randomized, Open Label, Active Control, Crossover Assignment治疗中心，随机，开放标签，主动控制，交叉转让  
Condition †条件†  Hepatitis B, Chronic肝炎，乙型，慢性  
Intervention †干预†  Drug: pegylated interferon alpha-2b药物：聚乙二醇干扰素α - 2b干扰素  
Study Arms / Comparison Groups研究武器/比较论坛  Experimental: PegIntron 1.0mcg/kg QW * 24 wks + 24 wks follow-up实验： PegIntron 1.0mcg/kg量子阱* 24周+ 24周的后续行动
Experimental: PegIntron 1.5mcg/kg QW * 24 wks + 24 wks follow-up实验： PegIntron 1.5mcg/kg量子阱* 24周+ 24周的后续行动
Experimental: PegIntron 1.5mcg/kg QW * 48 wks + 24 wks follow-up实验： PegIntron 1.5mcg/kg量子阱* 48周+ 24周的后续行动

Publications *出版物*   

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. *包括出版物所提供的数据供应商以及出版物所确定的全国临床试验标识符（轿车编号）中检索。  

Recruitment Information招聘信息  
Recruitment Status †招聘状况†  Active, not recruiting积极的，而不是招聘  
Enrollment †招生†  645 645  
Estimated Completion Date预计完成日期  September 2009 2009年9月  
Estimated Primary Completion Date估计完成初等教育日期  September 2009   (final data collection date for primary outcome measure) 2009年9月（最后数据收集日期为主要成果衡量）  
Eligibility Criteria †资格标准†  Inclusion Criteria:纳入标准：

Adults with chronic hepatitis B:成人慢性乙型肝炎：

Serum hepatitis B surface antigen positive for at least 6 months血清乙型肝炎表面抗原阳性至少6个月
Serum hepatitis B e antigen positive血清乙型肝炎e抗原阳性
Serum negative for hepatitis B surface and e antibodies血清阴性的乙型肝炎表面抗原和e
Serum hepatitis B virus DNA level greater than 20,000 IU/mL血清乙型肝炎病毒DNA水平大于20000国际单位/毫升
ALT 2- to 10-times the upper limit of normal备选案文2 - 10倍的上限正常
Compensated liver disease with certain minimum hematological and serum biochemical criteria补偿肝病与某些最低限度的血液和血清生化标准
Exclusion Criteria:排除标准：

Significant hepatic disease from an etiology other than hepatitis B virus重大的肝脏疾病从病因除B型肝炎病毒
Antiviral treatment for hepatitis within previous 6 months乙型肝炎抗病毒治疗前6个月内
History of severe psychiatric disease, especially depression历史上严重的精神疾病，尤其是抑郁症
Unstable or significant cardiovascular disease不稳定或重要的心血管疾病
Prolonged exposure to known hepatotoxins such as alcohol or drugs长期暴露于已知hepatotoxins ，如酒精或药物
Any condition that could interfere with the subject participating in and completing the study任何条件可能干扰这一问题的参与和完成的研究

Gender性别  Both两者  
Ages年龄  18 Years and older 18岁以上  
Accepts Healthy Volunteers接受健康志愿者  No否  
Contacts ††联系人† †   
Location Countries †地点国家†   
Expanded Access Status扩大进入状态   

Administrative Information行政信息  
NCT ID †轿车编号†  NCT00536263 NCT00536263  
Responsible Party责任方  Jasmine Sun, MD - Medical Director, China Country Operations, Schering-Plough茉莉花孙博士-医务主任，中国国家的业务中，先灵葆雅  
Secondary IDs ††中学阶段† †   
Study Sponsor †研究单位†  Schering-Plough先灵葆雅  
Collaborators ††合作者† †   
Investigators †调查†   
Information Provided By所提供的资料  Schering-Plough先灵葆雅  
Verification Date核查日期  April 2009 2009年4月  

† Required WHO trial registration data element. †要求世卫组织试验注册数据元素。
†† WHO trial registration data element that is required only if it exists. † †卫生组织审判登记数据元素，只需要如果存在的话。




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Links to all studies - primarily for crawlers 链接到的所有研究-主要用于搜寻器

英语原文：
Serum hepatitis B virus DNA level greater than 20,000 IU/mL
更好的翻译建议

放牛哥哥

性别  Both两者  
Ages年龄  18 Years and older 18岁以上  
Accepts Healthy Volunteers接受健康志愿者  No否  
Contacts ††联系人† †   
Location Countries †地点国家†   
Expanded Access Status扩大进入状态   

Administrative Information行政信息  
NCT ID †轿车编号†  NCT00536263 NCT00536263  
Responsible Party责任方  Jasmine Sun, MD - Medical Director, China Country Operations, Schering-Plough茉莉花孙博士-医务主任，中国国家的业务中，先灵葆雅  
Secondary IDs ††中学阶段† †   
Study Sponsor †研究单位†  Schering-Plough先灵葆雅  
Collaborators ††合作者† †   
Investigators †调查†   
Information Provided By所提供的资料  Schering-Plough先灵葆雅  
Verification Date核查日期  April 2009 2009年4月

痛苦的回忆

放牛,辛苦了!赶紧找个老婆吧