[介绍]临床试验:替诺福韦单独 对 恩曲他滨与替诺福韦

StephenW

治疗慢性乙型肝炎: 替诺福韦单独 对恩曲他滨替诺福韦

Tenofovir Alone Versus Tenofovir With Emtricitabine to Treat Chronic Hepatitis B
This study is currently recruiting participants.
Verified on January 2011 by National Institutes of Health Clinical Center (CC)

First Received on August 31, 2007.   Last Updated on January 13, 2011   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:     NCT00524173
Purpose

This study will test whether the combination of two medications, tenofovir and emtricitabine, are safer and more effective for treating chronic hepatitis B than tenofovir alone. Chronic hepatitis B is a liver disease caused by infection with the hepatitis B virus. Several medications, including standard and pegylated interferon and the anti-viral drugs lamivudine, adefovir, entecavir and telbivudine, are currently used to treat the disease. Problems are associated with all of these agents, however, including development of viral resistance with long-term therapy of the anti-virals. Since many patients require long-term therapy to prevent their disease from worsening, a major goal of new approaches to treatment is to prevent the development of viral resistance. Combination treatment has been shown to be an effective strategy in preventing this resistance.

Tenofovir is an anti-viral drug approved for use in patients with HIV infection. In small studies in patients infected with both HIV and hepatitis B, tenofovir lowered the level of hepatitis B virus in the blood, with no viral resistance reported when used for up to 5 years. Emtricitabine is an anti-viral drug similar to lamivudine and is effective at lowering viral load and improving liver damage.

Patients 18 years of age and older with chronic hepatitis B may be eligible for this study. Participants are admitted to the NIH Clinical Center for a complete medical history and examination, including blood and urine tests, chest X-ray, electrocardiogram, abdominal ultrasound, Fibroscan (ultrasound exam of the liver that measures the amount of scarring), bone mineral density scan and liver biopsy. They are then randomly assigned to take combination treatment with tenofovir plus emtricitabine or tenofovir alone for at least 48 weeks. During the treatment period, patients visit the Clinical Center for blood tests and a physical examination every 2 weeks for the first month and then every 4 to 12 weeks. After 48 weeks, patients are readmitted to the Clinical Center for a complete evaluation that includes all the tests done at the start of therapy, including a liver biopsy. Patients who seem to have improved with treatment may continue therapy for up to 192 weeks, when they are again admitted to the Clinical Center for a complete medical evaluation and liver biopsy. Patients whose condition has not improved after 48 weeks of treatment have their treatment changed or stopped and continue to have regular outpatient clinic visits for 24 more weeks.

Condition                                              Intervention                             Phase
Chronic Hepatitis B e Antigen Positive       Drug: Tenofovir/ & Emtricitabine   Phase II
Chronic Hepatitis B e Antigen Negative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tenofovir Disoproxil Fumarate Alone Versus Its Combination With Emtricitabine for Treatment of Chronic Hepatitis B

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Hepatitis B Vaccines
U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Maintained suppression of HBV DNA below 102 copies/ml (< 95 IU/ml, undetectable by current PCR-based assays, Roche Amplicor assay). [ Designated as safety issue: No ]


Secondary Outcome Measures:

Normalization of ALT levels and histological improvements which are expected to occur in all patients with full suppression of HBV DNA and in a proportion of those with partial suppression. Other endpoints will be loss of HBeAg and loss of HBsA. [ Designated as safety issue: No ]


Estimated Enrollment:100
Study Start Date: August 2007
Estimated Study Completion Date:January 2015
Estimated Primary Completion Date:January 2015 (Final data collection date for primary outcome measure)
Intervention Details:

Drug: Tenofovir/ & Emtricitabine
    N/A

Detailed Description:

Chronic hepatitis B is a major cause of cirrhosis, end-stage liver disease and hepatocellular carcinoma and affects approximately 1.25 million Americans. Six medications have been licensed for use in chronic hepatitis B in the United States, but their relative benefit and long-term efficacy remain unclear. In previous studies, we have shown that maintained suppression of HBV DNA can be achieved with nucleoside analogues and that suppression is associated with marked improvements in disease. In this randomized study, we propose to evaluate long-term therapy with tenofovir alone or in combination with emtricitabine (FTC). Forty treatment-naive patients with chronic hepatitis B will be enrolled in the primary study. After medical evaluation and liver biopsy, patients will be stratified by hepatitis B e antigen (HBeAg) status and randomized to receive either tenofovir alone or in combination with FTC. Treatment will be continued long-term (at least four years) and patients will be carefully monitored for side effects, serum aminotransferase and HBV DNA levels. Patients will undergo repeat liver biopsy and assessment of antiviral resistance at 1 and 4 years. The primary endpoint of therapy will be the maintained suppression of HBV DNA to below 10(2) copies/ml (lower limit of detection of current assays). The study will assess the relative efficacy and safety of combination versus mono-therapy. A separate group of 60 previously treated patients will also be enrolled and randomized to mono- or combination-therapy to assess the safety profile of these agents. The primary analysis will be conducted on the entire study cohort.





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StephenW

泰诺福韦单独对战与恩曲他滨替诺福韦治疗慢性乙型肝炎
这项研究是目前正在招募参加者。
在2011年1月由国家认可的卫生临床中心（CC）研究院

第一次收到8月31日，2007。最后更新于2011年1月13日更改的历史记录
主办单位：国立糖尿病，消化道和肾脏疾病研究所（NIDDK）
美国国立卫生临床中心（CC）机构：由提供的信息
ClinicalTrials.gov标识符：NCT00524173
  目的

这项研究将测试是否两种药物，替诺福韦和恩曲他滨的组合，更安全，更比替诺福韦治疗慢性乙型肝炎更有效。慢性乙型肝炎是一种肝脏疾病，与乙肝病毒感染引起的。一些药物，包括标准和聚乙二醇化干扰素和抗病毒的药物拉米夫定，阿德福韦，恩替卡韦和替比夫定，目前用于治疗这种疾病。问题都与所有这些药物，但是，包括长期的抗病毒药物治疗病毒抗药性的发展。由于许多患者需要长期治疗，以防止恶化的疾病，治疗新方法的主要目标是防​​止病毒抗药性的发展。联合治疗已被证明是一种有效的预防这种抵抗的策略。

泰诺福韦是一种抗病毒的药物获准用于艾滋病毒感染者。在与艾滋病毒和乙肝感染者，小规模研究泰诺福韦降低了乙肝病毒在血液中的水平，与文献报道时长达5年没有使用病毒的抵抗力。恩曲他滨是一种抗病毒的药物相似，拉米夫定，并在降低病毒载量，改善肝功能损害有效。

患者18岁，并患有慢性乙型肝炎旧年可能是本研究的资格。与会者承认，以美国国立卫生研究院临床中心为一个完整的病史和检查，包括血液和尿液检查，胸部X光，心电图，腹部超声，Fibroscan（超声对肝脏的措施的疤痕量考试），骨矿物密度扫描和肝活检。然后，他们随机分配到采取泰诺福韦加上至少48周恩曲他滨和替诺福韦单独治疗相结合。在治疗期间，患者前往抽血化验临床中心和体检的第一个月，每2周，然后每4至12周。 48周后，患者再次入院到一个完整的评估，包括所有在治疗开始进行测试，其中包括肝活检的临床中心。患者谁似乎与治疗好转可能继续上升至192周，当他们再次住进了一个完整的医疗评估和肝活检的临床中心治疗。患者因病情并没有好转后48周的治疗有其治疗改变或停止，并继续定期门诊诊所为24个星期的访问。

条件干预相
慢性乙型肝炎e抗原阳性
慢性B型肝炎e抗原阴性
药品：替诺福韦/恩曲他滨和
第二期

研究类型：介入
研究设计：分配：随机
端点分类：安全/药效研究
干预模式：并行作业
屏蔽：打开标签
主要目的：治疗
官方名称：富马酸泰诺福韦Disoproxil单独对战及其与恩曲他滨联合治疗慢性乙型肝炎的治疗

由NLM提供的资源链接：

MedlinePlus相关主题：乙肝肝炎
药物信息适用于：泰诺福韦替诺福韦disoproxil富马酸泰诺福韦Disoproxil乙肝疫苗
美国FDA资源

进一步的研究，由美国国立卫生临床中心（CC）研究所提供的详细资料：

主要结局指标：

    维护抑制HBV DNA低于102拷贝/毫升（<95 IU /毫升，按目前的基于PCR检测，罗氏AMPLICOR检测检测不到）。 [指定的安全问题：无]


次要终点指标：

    规范化的ALT水平和组织学的改善，预计将发生在抑制乙肝病毒DNA，并在充分与部分抑制所有患者的比例。其他终点将是HBeAg和损失的HBsA损失... ... [指定的安全问题：无]


预计招生：100
研究开始日期：2007年8月
研究预计完成日期：2015年1月
预计主要完成日期：2015年1月（最终数据为主要结果测量收集日期）
干预内容：

    药品：替诺福韦/恩曲他滨和
    N / A

详细说明：

慢性乙型肝炎是肝硬化，终末期肝病和肝癌的主要病因和影响大约125万美国人。六药已被授权在美国慢性乙型肝炎的使用，但它们的相对利益和远期疗效尚不清楚。在以前的研究中，我们已经表明，保持了HBV DNA抑制，可取得与核苷类似物，而抑制与疾病相关的明显改善。在这项随机研究中，我们建议评价泰诺福韦长期治疗单独或与恩曲他滨（FTC）的组合。四十治疗天真与慢性乙型肝炎患者将被登记在初步研究。经医生评估和肝活检，病人会被乙肝e抗原（HBeAg）状态，并随机接受替诺福韦单独或与FTC结合分层。治疗将继续长期（至少四年）和患者将被仔细的副作用，血清转氨酶和乙肝病毒DNA水平监测。患者将接受重复肝活检的病毒抗药性和评估在1和4年。治疗的主要终点将是抑制乙肝病毒DNA保持到低于10（2）拷贝/毫升（低电流检测的检测限）。这项研究将评估相结合的相对疗效与单一疗法和安全性。以前治疗的60例患者单独组也将参加，并随机单或联合疗法，以评估这些药物的安全性。主要的分析将进行整个研究队列。