A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
2013年8月12日 更新者：Gilead Sciences
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg).
Dose escalation or repetition will be governed by pre-specified safety and activity rules.
Subjects will be confined on either days 1-3 and/or days 8-10.
Follow-up visits are also required periodically through day 43.
Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
51
阶段
- 阶段1
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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Santurce、波多黎各、00909
- Fundacion De Investigacion de Diego
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Arkansas
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Little Rock、Arkansas、美国、72211
- Woodland International Research Group
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Florida
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DeLand、Florida、美国、32720
- Avail Clinical Research, LLC
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Orlando、Florida、美国、32809
- Orlando Clinical Research Center
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Missouri
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Kansas City、Missouri、美国、64131
- Kansas City Gastroenterology and Hepatology
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New Jersey
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Berlin、New Jersey、美国、08009
- Comprehensive Clinical Research
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Willingboro、New Jersey、美国、08046
- CRI Worldwide, LLC
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New York
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New York、New York、美国、10019
- Clinilabs
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19139
- CRI Worldwide, LLC
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Texas
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San Antonio、Texas、美国、78215
- Alamo Medical Research
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Utah
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Salt Lake City、Utah、美国、84106
- Lifetree Clinical Research
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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 65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:
- Males and Females 18-65 years old
- Chronic HCV infection for at least 6 months, treatment naive
- HCV Viral load > 100,000 IU/mL at Screening
- Monoinfection with HCV 1 genotype
- Hepatitis B surface antigen negative
- Screening ECG without clinically significant abnormalities
- BMI 18-33 kg/m^2
- Creatinine clearing > 70 mL/min
- Negative pregnancy test at screening
Exclusion Criteria:
- Pregnant or lactating subjects
- Co-infection with hepatitis B virus (HBV) or HIV
- History of Gilberts disease
- Particular abnormal laboratory parameters
- Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
- Evidence of hepatocellular carcinoma
- On-going alcohol abuse
- Positive uring drug screen
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：0.3毫克 GS-9620
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This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort.
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg).
Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
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实验性的：1毫克GS-9620
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This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort.
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg).
Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
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实验性的：2毫克GS-9620
|
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort.
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg).
Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
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实验性的：4毫克GS-9620
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This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort.
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg).
Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
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实验性的：0.3mg GS-9620 QW x 2 剂
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This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort.
Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
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实验性的：1mg GS-9620 QW x 2 剂
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This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort.
Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
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实验性的：2mg GS-9620 QW x 2 剂
|
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort.
Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
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实验性的：4mg GS-9620 QW x 2 剂
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This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort.
Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of adverse events in single and multiple doses of GS-9620
大体时间：Periodically Day 1 to 6 months
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Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements
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Periodically Day 1 to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
大体时间：Day 1 and Day 8
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Single ascending dose (SAD) cohorts: serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose. Multiple ascending dose (MAD) cohorts: serial blood samples will be collected on Day 8 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose. |
Day 1 and Day 8
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Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
大体时间：Days 1, 2, 3, 5, 8
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SAD cohorts: Whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hour Post-dose, Day 2, Day 3, Day 5, Day 8 MAD cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hours Post-dose, Day 2, Day 3, Day 5, Day 8: Pre-dose and 8 hours Post-dose, Day 9, Day 10, Day 12, and Day 15 |
Days 1, 2, 3, 5, 8
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Reduction of hepatitis C (HCV) RNA viral load from baseline
大体时间：Screening, Baseline, Day 8 or 15
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SAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits. MAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-dose, 9, 10, 15, and both Follow-Up Visits. |
Screening, Baseline, Day 8 or 15
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2012年3月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2012年12月1日
研究注册日期
首次提交
2012年3月23日
首先提交符合 QC 标准的
2012年5月2日
首次发布 (估计)
2012年5月4日
研究记录更新
最后更新发布 (估计)
2013年8月13日
上次提交的符合 QC 标准的更新
2013年8月12日
最后验证
2013年8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.