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Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients

2014年3月31日 更新者：Gilead Sciences

A Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Standard of Care (Pegylated Interferon and Ribavirin) in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1

Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

64

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

  • 波多黎各
      • Santurce、波多黎各、00909
        • Fundacion De Investigacion de Diego
  • 美国
    • California
      • San Francisco、California、美国、94115
        • Quest Clinical Research
    • Florida
      • Gainesville、Florida、美国、32610
        • University of Florida
      • Orlando、Florida、美国、32803
        • Orlando Immunology Center
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University
    • Texas
      • San Antonio、Texas、美国、78215
        • Alamo Medical Research Center
    • Washington
      • Seattle、Washington、美国、98101
        • Virginia Mason Medical Center

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:

  • Treatment-naive males and females, 18-65 years of age
  • Genotype 1 HCV infection
  • Negative pregnancy test for females of childbearing age
  • Females of childbearing age and males with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

  • Hepatitis B or HIV infection
  • Pregnant or breast feeding females or male partners of pregnant females
  • Previous interferon or ribavirin-based therapy or investigational anti-HCV agent
  • History or evidence of medical condition associated with chronic liver disease other than HCV

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：单组作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Sofosbuvir 100 mg+PEG+RBV
Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
药品：聚乙二醇
每周一次皮下注射聚乙二醇化干扰素 alfa-2a (PEG) 180 μg。
其他名称：
  • 派罗欣®
药品：Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
其他名称：
  • 科佩格斯®
实验性的：Sofosbuvir 200 mg+PEG+RBV
Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
药品：聚乙二醇
每周一次皮下注射聚乙二醇化干扰素 alfa-2a (PEG) 180 μg。
其他名称：
  • 派罗欣®
药品：Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
其他名称：
  • 科佩格斯®
实验性的：Sofosbuvir 400 mg+PEG+RBV
Participants received sofosbuvir 400 mg (4 x 100 mg tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
药品：聚乙二醇
每周一次皮下注射聚乙二醇化干扰素 alfa-2a (PEG) 180 μg。
其他名称：
  • 派罗欣®
药品：Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
其他名称：
  • 科佩格斯®
有源比较器：Placebo+PEG+RBV
Participants received placebo to match sofosbuvir (4 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
药品：聚乙二醇
每周一次皮下注射聚乙二醇化干扰素 alfa-2a (PEG) 180 μg。
其他名称：
  • 派罗欣®
药品：RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
其他名称：
  • 科佩格斯®
药品：Placebo
Placebo to match sofosbuvir administered orally once daily

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
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
大体时间：Baseline to Week 4
Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.
Baseline to Week 4

次要结果测量

结果测量
措施说明
大体时间
Change in Circulating HCV RNA at Week 4
大体时间：Baseline to Week 4
Baseline to Week 4
Percentage of Participants With Rapid Virologic Response at Week 4
大体时间：Week 4
Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.
Week 4
Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment
大体时间：Post-treatment Weeks 12 and 24
SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV).
Post-treatment Weeks 12 and 24
Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir.

Cmax is defined as the maximum concentration of drug.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose

The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir).

AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)

The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir).

AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of GS-331007: Cmax at Day 0
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007: Cmax at Day 27
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of GS-566500: Cmax at Day 0
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of GS-566500: Cmax at Day 27
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27
大体时间：Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)
Percentage of Participants Who Developed Resistance to Sofosbuvir
大体时间：Baseline to Week 4
Baseline to Week 4

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

Gilead Sciences

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1月1日

初级完成 (实际的)

2010年4月1日

研究完成 (实际的)

2011年8月1日

研究注册日期

首次提交

2010年1月21日

首先提交符合 QC 标准的

2010年1月21日

首次发布 (估计)

2010年1月22日

研究记录更新

最后更新发布 (估计)

2014年4月17日

上次提交的符合 QC 标准的更新

2014年3月31日

最后验证

2014年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • P7977-0221

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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