VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
2014年5月14日 更新者：Janssen Infectious Diseases BVBA
A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.
研究概览
地位
完全的
条件
详细说明
This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.
Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.
研究类型
介入性
注册 (实际的)
744
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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Mex Ctity、墨西哥
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Mexico、墨西哥
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Monterrey、墨西哥
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Graz N/A、奥地利
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Linz、奥地利
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Wien、奥地利
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Campinas、巴西
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Salvador、巴西
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Santo Andre、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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Bochum、德国
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Essen、德国
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Frankfurt、德国
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Hamburg、德国
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Kiel、德国
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Mainz、德国
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Regensburg、德国
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Antwerpen、比利时
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Brussels、比利时
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Genk、比利时
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Gent、比利时
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Leuven、比利时
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Liege、比利时
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Clichy、法国
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Creteil、法国
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Grenoble、法国
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Lille、法国
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Lyon、法国
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Paris、法国
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Pessac、法国
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Vandoeuvre Les Nancy、法国
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Villejuif Cedex、法国
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Bialystok、波兰
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Bydgoszcz、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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Adelaide、澳大利亚
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Camperdown、澳大利亚
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Clayton、澳大利亚
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Darlinghurst、澳大利亚
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Fitzroy、澳大利亚
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Greenslopes、澳大利亚
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Melbourne、澳大利亚
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Perth、澳大利亚
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Dublin、爱尔兰
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Dublin 9、爱尔兰
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Göteborg、瑞典
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Malmö、瑞典
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Stockholm、瑞典
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California
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La Jolla、California、美国
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Los Angeles、California、美国
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San Diego、California、美国
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Colorado
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Aurora、Colorado、美国
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Connecticut
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New Haven、Connecticut、美国
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Florida
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Bradenton、Florida、美国
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Jacksonville、Florida、美国
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Georgia
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Atlanta、Georgia、美国
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Marietta、Georgia、美国
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Illinois
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Chicago、Illinois、美国
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Downers Grove、Illinois、美国
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Louisiana
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New Orleans、Louisiana、美国
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Maryland
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Lutherville、Maryland、美国
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Missouri
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Kansas City、Missouri、美国
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New Hampshire
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Lebanon、New Hampshire、美国
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New Jersey
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Egg Harbor Twp、New Jersey、美国
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New Mexico
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Santa Fe、New Mexico、美国
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New York
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New York、New York、美国
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North Carolina
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Charlotte、North Carolina、美国
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Durham、North Carolina、美国
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Statesville、North Carolina、美国
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Winston Salem、North Carolina、美国
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Ohio
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Cincinnati、Ohio、美国
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Pennsylvania
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Allentown、Pennsylvania、美国
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Hershey、Pennsylvania、美国
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Philadelphia、Pennsylvania、美国
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Pittsburgh、Pennsylvania、美国
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Rhode Island
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Providence、Rhode Island、美国
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South Carolina
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Charleston、South Carolina、美国
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Columbia、South Carolina、美国
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Texas
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Arlington、Texas、美国
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Dallas、Texas、美国
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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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Norfolk、Virginia、美国
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Washington
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Seattle、Washington、美国
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Birmingham、英国
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Edinburgh、英国
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Glasgow、英国
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London、英国
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Manchester、英国
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Barcelona、西班牙
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Barcelona N/A、西班牙
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Madrid、西班牙
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Malaga N/A、西班牙
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Santander N/A、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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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:
- Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
- Patients should not have had any previous treatment for hepatitis C
- Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
- Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
- A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.
Exclusion Criteria:
- Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
- Patient has a pre-existing psychiatric condition
- Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
- Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
- Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：001 T(q8h) / PR
Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
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Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
750 mg (2 oral tablets) every 8 hours for 12 weeks
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实验性的：002 T(b.i.d.) / PR
Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
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Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
750 mg (2 oral tablets) every 8 hours for 12 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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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
大体时间：End of trial, 12 weeks after last planned dose
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The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned).
SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
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End of trial, 12 weeks after last planned dose
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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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Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
大体时间：End of trial, 24 weeks after last planned dose
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The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication.
SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time.
Consequently, by definition of SVR12, they were counted as not having achieved SVR12.
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End of trial, 24 weeks after last planned dose
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Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
大体时间：End of trial, 72 weeks after the start of study medication
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The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned).
SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).
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End of trial, 72 weeks after the start of study medication
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Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
大体时间：Baseline, Week 4 and Week 4+12.
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The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.
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Baseline, Week 4 and Week 4+12.
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Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
大体时间：Week 4, 12, 24, 32, 40
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The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.
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Week 4, 12, 24, 32, 40
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Percentage of Participants Who Relapsed During Follow-up Period
大体时间：During Follow-Up (24 weeks after the last dose of study drug)
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The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
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During Follow-Up (24 weeks after the last dose of study drug)
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Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
大体时间：End of trial, 12 weeks after the last planned dose
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The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.
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End of trial, 12 weeks after the last planned dose
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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
- Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.
- Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hezode C, Rizzetto M, Parana R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.
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
2010年12月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2010年10月28日
首先提交符合 QC 标准的
2010年11月12日
首次发布 (估计)
2010年11月16日
研究记录更新
最后更新发布 (估计)
2014年6月4日
上次提交的符合 QC 标准的更新
2014年5月14日
最后验证
2014年5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
- CR013711
- OPTIMIZE-HCV (其他标识符：Janssen Infectious Diseases BVBA)
- VX-950-C211 (其他标识符：Janssen Infectious Diseases BVBA)
- 2010-021628-84 (EudraCT编号)
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.
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