An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection
2013年8月27日 更新者：Tibotec BVBA
A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection
The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.
研究概览
详细说明
This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4. The study consists of 4 parts: Screening period (6-week); Investigational Treatment period (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo); Standard Treatment period (consists of 46 or 48-week standard treatment); and Follow-up period (24-week).
The activity of telaprevir will be evaluated by early viral kinetic parameters along with viral response and pharmacokinetic assessments during the investigational treatment phase.
Participants' safety will be monitored throughout the study.
研究类型
介入性
注册 (实际的)
24
阶段
- 阶段2
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: - Participant has chronic Genotype 4 Hepatitis C infection
- Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level greater than 10,000 International unit per milliliter (IU/mL) at Screening
- Participant never received treatment for HCV
- Participant was to be in good health (besides HCV infection), in the opinion of the Investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram [ECG]), with any chronic medical conditions under stable medical control
- Participant had to be willing to refrain from the concomitant use of any medications or substances Exclusion Criteria: - Participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the Investigator's opinion would compromise the participant's safety and/or compliance with study procedures
- Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
- Female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
- Participant has hypersensitivity to tartrazine
- Participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months
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
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin
Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 2 to 50.
|
Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.
Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.
Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
|
|
实验性的：Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48.
|
Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.
Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.
Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
|
|
有源比较器：Placebo+Pegylated-interferon-alfa-2a+Ribavirin
Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa 2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48.
|
Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.
Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.
|
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 |
|---|---|---|
|
Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15
大体时间：Baseline and Day 15
|
The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification [LLOQ=25 IU/mL] of the viral load assay).
Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0.
This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.
|
Baseline and Day 15
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Viral Response (Undetectable HCV RNA)
大体时间：Day 15 up to EOT (Week 48/50 or early discontinuation)
|
Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation.
In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.
|
Day 15 up to EOT (Week 48/50 or early discontinuation)
|
|
Median Time to First Viral Response (Undetectable HCV RNA)
大体时间：Up to Week 48/50
|
Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.
|
Up to Week 48/50
|
|
Number of Participants With Viral Breakthrough (Detectable HCV RNA)
大体时间：Day 8, Day 12, Day 15, Week 24/26 and Week 36/38
|
Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]).
In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.
|
Day 8, Day 12, Day 15, Week 24/26 and Week 36/38
|
|
Percentage of Participants With Sustained Viral Response (SVR)
大体时间：Week 12 and 24 after the last dose of study medication
|
Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.
|
Week 12 and 24 after the last dose of study medication
|
|
Percentage of Participants With Relapse
大体时间：Week 24 after EOT (Week 48/50 or early discontinuation)
|
Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation).
Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.
|
Week 24 after EOT (Week 48/50 or early discontinuation)
|
|
Area Under the Serum Concentration-Time Curve (AUC)
大体时间：Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
|
The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.
|
Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
|
|
Maximum Serum Concentration (Cmax) of Telaprevir
大体时间：Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
|
The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
|
Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
|
|
Pre-Dose Serum Concentration (C[0h]) of Telaprevir
大体时间：0 hour (pre-dose) at Day 15
|
The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
|
0 hour (pre-dose) at Day 15
|
|
Minimum Serum Concentration (Cmin) of Telaprevir on Day 15
大体时间：Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15
|
The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
Cmin on Day 15 is reported here.
|
Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15
|
|
Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir
大体时间：Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
|
The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test).
|
Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
|
|
Average Steady-State Serum Concentration (Css,av) of Telaprevir
大体时间：Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
|
The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
|
Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
|
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。
赞助
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
2008年1月1日
初级完成 (实际的)
2010年1月1日
研究完成 (实际的)
2010年1月1日
研究注册日期
首次提交
2007年12月20日
首先提交符合 QC 标准的
2007年12月26日
首次发布 (估计)
2007年12月27日
研究记录更新
最后更新发布 (估计)
2013年9月9日
上次提交的符合 QC 标准的更新
2013年8月27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.