Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C
2012年6月21日 更新者:Bausch Health Americas, Inc.
Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C
The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.
研究概览
详细说明
This Phase 2b multicenter study, which is being conducted solely in the United States, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks.
After the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy.
The RVR at CT Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined.
The differences in virological response during treatment and end of follow-up between African-Americans and Caucasians (non-Hispanics), as well as a correlation between duration of viral negativity (DVN) and sustained virologic response (SVR) based on race and dosing regimen, will also be assessed.
研究类型
介入性
注册
100
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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California
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Los Angeles、California、美国、90033
- University of Southern California -- Keck School of Medicine
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San Mateo、California、美国、94403
- San Mateo Medical Center
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Florida
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Bradenton、Florida、美国、34205
- Bach and Godofsky
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Miami、Florida、美国、33136
- University of Miami -- Center for Liver Diseases
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Georgia
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Atlanta、Georgia、美国、30309
- Digestive Healthcare of Georgia
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Maryland
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Laurel、Maryland、美国、20707
- Maryland Digestive Disease Research
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New Jersey
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Egg Harbor Township、New Jersey、美国、08234
- Atlantic Gastroenterology Associates
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New York
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Plainview、New York、美国、11803
- Liver Center of Long Island
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University -- Gastroenterology and Hepatology
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Utah
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Salt Lake City、Utah、美国、84121
- Mountain West Gastroenterology -- Research Office
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Virginia
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Fairfax、Virginia、美国、22031
- Metropolitan Research -- Georgetown Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Treatment-naive, genotype 1 only, compensated, chronic hepatitis C infected Caucasian or African-American patients
- Body weight greater than 61 kg and not more than 87.3 kg
- HCV RNA greater than 2 million copies/mL
- Elevated measured or historical alanine aminotransferase
- Hemoglobin at least 12.0 g/dL for females and at least 13.0 g/dL for males
- Calculated creatinine clearance greater than 70 mL/min
Exclusion Criteria:
- Cirrhosis of the liver
- Alanine aminotransferase greater than 3 times the upper limit of normal
- Severe neuropsychiatric disorders
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
- Other co-morbid chronic viral infections including hepatitis B and the human immunodeficiency virus (HIV)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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Efficacy: The proportion of patients with hepatitis C virus (HCV) RNA undetectable or with at least a 2-log drop from baseline at CT Week 4 in the viramidine pre-load group versus the viramidine standard dosing group.
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Safety: Evaluation of adverse events (AEs).
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Safety: Physical exams
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Safety: Vital signs
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Safety: Laboratory tests
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次要结果测量
结果测量 |
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Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年11月1日
研究完成 (实际的)
2007年5月1日
研究注册日期
首次提交
2006年3月17日
首先提交符合 QC 标准的
2006年3月17日
首次发布 (估计)
2006年3月21日
研究记录更新
最后更新发布 (估计)
2012年6月22日
上次提交的符合 QC 标准的更新
2012年6月21日
最后验证
2012年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
丙型肝炎,慢性的临床试验
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Meir Medical Center完全的开发从数字立体光盘图像测量 C/D 比的新技术 | C/D 测量的观察者内再现性 | C/D 测量的观察者间变异性
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Haisco Pharmaceutical Group Co., Ltd.完全的
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University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
聚乙二醇干扰素α-2b的临床试验
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Merck Sharp & Dohme LLCIntegrated Therapeutics Group终止
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National Taiwan University Hospital招聘中
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Merck Sharp & Dohme LLC完全的
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National Taiwan University HospitalNational Science Council, Taiwan未知