An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants (QUEST-2)
2014年6月10日 更新者：Janssen R&D Ireland
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before.
Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.
研究概览
地位
完全的
条件
详细说明
This is a randomized, double-blind (neither physician or participant knows the name of the assigned drug), placebo-controlled study of TMC435 in participants who are infected with genotype 1 hepatitis C virus who have never received treatment for this before.
Participants in this study will also receive two other drugs for their infection (either peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon alfa-2b (PegIntron®) and ribavirin (Rebetol®).
The purpose of the study is to investigate if TMC435 is superior to placebo in reducing hepatitis C virus to an undetectable level 24 weeks after the end of treatment.
For the first 12 weeks, participants will take TMC435 or placebo, plus peginterferon and ribavirin.
For the next 12 weeks, participants will take peginterferon and ribavirin only.
After that, some participants will continue to take peginterferon and ribavirin for up to 24 additional weeks.
Other participants will stop taking peginterferon and ribavirin.
The study doctor will inform each participant about how to take their study medication and when they should stop taking it.
After a participant stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study.
The total duration of the study is 78 weeks (including screening).
Participants will be monitored for safety throughout the study.
Study assessments at each study visit may include but are not limited to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical activity of your heart), participant questionnaires, and physical examinations.
TMC435 will be taken as an oral capsule of 150 mg once per day.
Peginterferon (Pegasys ®) will be given as an injection of 180 µg once each week.
Peginterferon (PegIntron®) will be given as an injection once each week and the dose will depend on your body weight.
Ribavirin will be taken as a tablet (Copegus ®) or a capsule (Rebetol ®) twice each day and the dose will depend on your body weight.
研究类型
介入性
注册 (实际的)
393
阶段
- 第三阶段
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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Plovdiv、保加利亚
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Sofia、保加利亚
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Wien、奥地利
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Salvador、巴西
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Sao Paulo、巴西
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São Paulo、巴西
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Berlin、德国
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Düsseldorf、德国
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Freiburg、德国
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Halle (Saale)、德国
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Hannover、德国
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Kiel、德国
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Leipzig、德国
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Munchen、德国
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Münster、德国
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Ulm、德国
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Bratislava、斯洛伐克
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Martin、斯洛伐克
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Antwerpen、比利时
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Brugge、比利时
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Brussel、比利时
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Brussels、比利时
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Gent、比利时
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Leuven、比利时
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Clichy、法国
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Creteil N/A、法国
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Nice N/A、法国
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Paris、法国
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Vandoeuvre Les Nancy、法国
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Bialystok、波兰
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Bydgoszcz、波兰
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Chorzow、波兰
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Czeladz、波兰
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Kielce、波兰
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Krakow、波兰
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Warszawa、波兰
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Santurce、波多黎各
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Ankara、火鸡
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Istanbul、火鸡
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Izmir、火鸡
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California
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Los Angeles、California、美国
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Florida
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Jacksonville、Florida、美国
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Orlando、Florida、美国
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Georgia
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Atlanta、Georgia、美国
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Kentucky
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Crestview Hills、Kentucky、美国
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Louisiana
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New Orleans、Louisiana、美国
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Minnesota
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Saint Paul、Minnesota、美国
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Tennessee
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Germantown、Tennessee、美国
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Texas
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Houston、Texas、美国
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San Antonio、Texas、美国
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Virginia
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Falls Church、Virginia、美国
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Amsterdam Zuidoost、荷兰
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Leiden、荷兰
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Coimbra、葡萄牙
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Lisboa、葡萄牙
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Porto、葡萄牙
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Barcelona、西班牙
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Madrid、西班牙
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Sevilla N/A、西班牙
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Valencia、西班牙
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Buenos Aires、阿根廷
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Rosario, Santa Fe、阿根廷
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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 及以上 (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:
- Genotype 1 hepatitis C infection (confirmed at screening)
- Participant has not received any prior treatment for hepatitis C
- Participant must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
- Must agree to use 2 forms of effective contraception throughout study (both males and females)
Exclusion Criteria:
- Infection with HIV or non genotype 1 hepatitis C
- Liver disease not related to hepatitic C infection
- Hepatic decompensation
- Significant laboratory abnormalities or other active diseases
- Pregnant or planning to become pregnant
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：TMC435
TMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 24 or 48 weeks
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150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks
One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.
其他名称：
200-mg tablets of ribavirin (Copegus or Rebetol) (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
其他名称：
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安慰剂比较：Placebo
Placebo 150 mg capsule once daily for 12 weeks in addition peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 48 weeks
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One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.
其他名称：
200-mg tablets of ribavirin (Copegus or Rebetol) (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
其他名称：
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks
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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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在计划治疗结束 12 周后达到持续病毒学应答的参与者百分比 (SVR12)
大体时间：第 36 周或第 60 周
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下表显示了每个治疗组中达到 SVR12 的参与者百分比，SVR12 定义为计划治疗结束后 12 周血浆丙型肝炎病毒核糖核酸检测不到的参与者百分比。
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第 36 周或第 60 周
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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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第 72 周时达到持续病毒学应答的参与者百分比 (SVRW72)
大体时间：第 72 周
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下表显示了每个治疗组中达到 SVRW72 的参与者百分比，定义为在治疗结束 (EOT) 和第 72 周时血浆丙型肝炎病毒核糖核酸水平检测不到的参与者百分比。
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第 72 周
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在计划治疗结束 24 周后达到持续病毒学应答的参与者百分比 (SVR24)
大体时间：第 48 周或第 72 周
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下表显示了每个治疗组中达到 SVR24 的参与者百分比，SVR24 定义为在计划治疗结束 24 周后血浆丙型肝炎病毒核糖核酸水平检测不到的参与者百分比。
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第 48 周或第 72 周
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在计划治疗结束 (SVR4) 后 4 周达到持续病毒学应答的参与者百分比
大体时间：第 28 周或第 52 周
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下表显示了每个治疗组中达到 SVR4 的参与者百分比，定义为计划治疗结束后 4 周血浆丙型肝炎病毒核糖核酸水平检测不到的参与者百分比。
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第 28 周或第 52 周
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参与者实现快速病毒学反应 (RVR) 的百分比
大体时间：第四周
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下表显示了每个治疗组中达到 RVR 的参与者百分比，RVR 定义为接受 4 周治疗后血浆丙型肝炎病毒核糖核酸水平检测不到。
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第四周
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参与者实现完全早期病毒学应答 (cEVR) 的百分比
大体时间：第 12 周
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下表显示了每个治疗组中达到 cEVR 的参与者百分比，cEVR 定义为在第 12 周时血浆丙型肝炎病毒核糖核酸水平检测不到。
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第 12 周
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第 4 周时丙型肝炎病毒 (HCV) 核糖核酸 (RNA) 从基线减少 <1 log10 的参与者百分比
大体时间：第四周
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下表显示了第 4 周时 HCV RNA 减少 <1 log10 的每个治疗组参与者的百分比。
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第四周
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第 4 周丙型肝炎病毒 (HCV) 核糖核酸 (RNA) 水平 >1000 IU/mL 的参与者百分比
大体时间：第四周
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下表显示了第 4 周时每个治疗组中 HCV RNA 水平 >1000 IU/mL 的参与者百分比。
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第四周
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不同时间点病毒突破的参与者百分比
大体时间：直到第 48 周
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下表显示了在不同时间点出现病毒突破的参与者百分比，定义为血浆 HCV 核糖核酸 (RNA) 水平从达到的最低水平（即在介于基线和当前值之间），或者血浆 HCV RNA 先前低于定量限（可检测到 25 IU/mL）或检测不到（<25 IU/mL）的参与者的确认血浆 HCV RNA 水平大于 100 IU/mL检测不到）。
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直到第 48 周
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从治疗结束到病毒复发的时间
大体时间：直到第 72 周
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下表显示了病毒复发的平均天数，定义为参与者在随访期间确认血浆 HCV RNA 检测不到（<25 IU） /mL 检测不到）在治疗结束时。
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直到第 72 周
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Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
大体时间：Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
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The table below shows changes from baseline in log10 HCV RNA.
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Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
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Log10 丙型肝炎病毒 (HCV) 核糖核酸 (RNA) 的实际值
大体时间：第 3 天、第 1 周、第 4 周、第 12 周、第 24 周和第 48 周
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下表显示了 log10 HCV RNA 水平的实际值。
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第 3 天、第 1 周、第 4 周、第 12 周、第 24 周和第 48 周
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Percentage of Participants With On-treatment Virologic Response at All Time Points
大体时间：Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42
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The table below shows the percentage of participants with Hepatitis C Virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of HCV-Infected participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.
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Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42
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The Percentage of Participants Achieving a Early Virologic Response (EVR)
大体时间：Week 12
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The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.
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Week 12
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The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)
大体时间：Weeks 4 and 12
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The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.
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Weeks 4 and 12
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无反应的参与者百分比
大体时间：第 12 周
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下表显示了无效反应参与者的百分比，无效反应定义为与基线相比，第 12 周丙型肝炎病毒核糖核酸减少 <2 log10。
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第 12 周
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Percentage of Participants With Partial Response
大体时间：Week 12
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The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.
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Week 12
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病毒突破参与者的百分比
大体时间：直到第 48 周
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下表显示了病毒突破的参与者百分比，定义为血浆丙型肝炎病毒 (HCV) 核糖核酸 (RNA) 水平从达到的最低水平（即测量的最低值）确认增加超过 1 log10 IU/mL介于基线和当前值之间），或者血浆 HCV RNA 先前低于定量限（可检测到 25 IU/mL）或检测不到（<25 IU/毫升检测不到）。
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直到第 48 周
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Percentage of Participants With Viral Relapse
大体时间：Up to Week 72
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The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.
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Up to Week 72
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由于治疗持续时间规则，在第 24 周完成所有研究治疗的参与者百分比
大体时间：第 24 周
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下表显示了 TMC435 治疗组中满足治疗持续时间规则的参与者的百分比（即丙型肝炎病毒 [HCV] 核糖核酸 [RNA] 水平 <25 IU/mL 在第 4 周可检测或检测不到，HCV RNA 检测不到第 12 周时的水平）并完成 PegIFNα-2a 和 RBV 治疗 24 周。
不符合 RGT 标准的 TMC435 治疗组参与者和安慰剂组参与者接受了 PegIFNα-2a 和 RBV 治疗 48 周。
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第 24 周
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治疗失败的参与者百分比
大体时间：第 48 周
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下表显示了治疗失败的参与者百分比，定义为在实际治疗结束时确认可检测到的丙型肝炎病毒核糖核酸水平。
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第 48 周
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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable
大体时间：Up to Week 48
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The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.
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Up to Week 48
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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable
大体时间：Up to Week 48
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The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable.
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Up to Week 48
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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL
大体时间：Up to Week 48
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The table below shows the median time in days to reach HCV RNA levels <100 IU/mL.
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Up to Week 48
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Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL
大体时间：Up to Week 48
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The table below shows the median time in days to reach HCV RNA levels <1000 IU/mL.
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Up to Week 48
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The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)
大体时间：Up to Week 48
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The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 164 of 257 participants in the TMC435 treatment group and 79 of 134 participants in the Placebo group had ALT values at baseline that were out of the normal range.).
Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.
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Up to Week 48
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丙氨酸转氨酶 (ALT) 水平正常化的中位时间
大体时间：直到第 48 周
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下表显示了 ALT 水平正常化的中位时间（以周为单位）。
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直到第 48 周
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Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
大体时间：At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12
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The table below shows the mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435.
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At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12
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Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)
大体时间：Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12
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The table below shows the mean (standard deviation) of C0h values of TMC435.
NOTE: the timing of collection of blood samples post-dose for analysis at Week 2, 4, 8, and 12 was not specifed; only the interval was between blood samples was specified (ie, 2 samples collected 2 hours apart at Week 2, 4, 8, and 12).
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Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12
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Plasma Concentration of TMC435: Systemic Clearance (CL)
大体时间：At protocol-specified time points at Weeks 2, 4, 8, and 12
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The table below shows the mean (standard deviation) of CL values of TMC435.
NOTE: the pre-dose CL values taken at Weeks, 2, 4, 8, and 12 were averaged and then the mean values from all participants were averaged to provide the final value reported below.
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At protocol-specified time points at Weeks 2, 4, 8, and 12
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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores
大体时间：Baseline to Week 60 and Week 72
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Study participants completed FSS questionnaires during study visits before treatment and throughout follow-up to rate the severity and impact of fatigue experienced in the preceding 2 weeks.
FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst fatigue]; the possible score range from baseline to Week 60 would be 60-420 and to Week 72 would be 72-504.
The average FSS total score from baseline to Week 60 and to Week 72 was calculated for each participant and then the average of those values were calculated to show the average FSS total score for each treatment group.
The null hypothesis was that there would be no difference between the treatment arms in the FSS total score.
The Table below shows the lease squares (LS) mean estimates of the area under the curve (AUC) at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.
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Baseline to Week 60 and Week 72
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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment
大体时间：Baseline to Week 60 and Week 72
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Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants throughout the study.
WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity).
The average WPAI score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI score for each treatment group.
The null hypothesis was there is no statistically significant difference between the treatment groups in the AUC for the change from baseline to Week 72 (AUC72) in WPAI Productivity Scores.
The Table below shows WPAI Productivity Scores at Week 72 (as well as at Week 60) from the model used to calculate the AUC and the statistical comparison between treatment groups.
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Baseline to Week 60 and Week 72
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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment
大体时间：Baseline to Week 60 and Week 72
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Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6.
The possible impairment in WPAI daily activity score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in daily activities.
The average WPAI impairment in daily activity score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI impairment in daily activity score for each treatment group.
The null hypothesis was there is no statistically significant difference between the treatment arms in the AUC for the change from baseline to Week 72 (AUC72) in WPAI impairment in daily activity scores.
The Table below shows the WPAI Impairment in daily activity scores at Week 72 (as well as at Week 60) and the statistical analysis between treatment groups.
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Baseline to Week 60 and Week 72
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Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment
大体时间：Baseline to Week 60 and Week 72
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Hours missed from work because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work).
The possible WPAI WPAI absenteeism score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in WPAI absenteeism.
The average WPAI absenteeism score from baseline to Week 60/72 was calculated for each participant and then the average of those values calculated for each treatment group.
The area under the curve (AUC60/AUC72) over time from baseline to Week 60/72 was derived from a piecewise-linear model allowing the slopes to change at Week 4, 12, 24, 36, 48 and 60.
The null hypothesis was there is no statistically significant difference between the treatment arms in the area under the curve (AUC) from baseline to Week 72 (AUC72) in WPAI absenteeism score.
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Baseline to Week 60 and Week 72
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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。
一般刊物
- Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.
- Manns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, Janczewska E, Villamil F, Scott J, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014 Aug 2;384(9941):414-26. doi: 10.1016/S0140-6736(14)60538-9. Epub 2014 Jun 4. Erratum In: Lancet. 2016 Apr 30;387(10030):1816.
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
2011年3月1日
初级完成 (实际的)
2013年2月1日
研究完成 (实际的)
2013年2月1日
研究注册日期
首次提交
2011年1月7日
首先提交符合 QC 标准的
2011年2月3日
首次发布 (估计)
2011年2月7日
研究记录更新
最后更新发布 (估计)
2014年6月13日
上次提交的符合 QC 标准的更新
2014年6月10日
最后验证
2014年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CR017380
- TMC435-TiDP16-C216 (其他标识符：Janssen R&D Ireland)
- 2010-021174-11 (EudraCT编号)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.