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A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

2013年7月15日 更新者：Hoffmann-La Roche

A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

研究概览

地位

完全的

条件

干预/治疗

详细说明

During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA <15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available.

Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.

研究类型

介入性

注册 (实际的)

235

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

  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 2B7
    • British Columbia
      • Vancouver、British Columbia、加拿大、V6Z 2K5
    • Ontario
      • Hamilton、Ontario、加拿大、L8N 4A6
      • Mississauga、Ontario、加拿大、L5M 4N4
  • 墨西哥
      • Guadalajara、墨西哥、44160
      • Guadalajara、墨西哥、44670
      • Mexicali、墨西哥、21000
      • Mexico City、墨西哥、14050
      • Mexico Df、墨西哥、11649
      • Puebla、墨西哥、72560
  • 奥地利
      • Graz、奥地利、8036
      • Innsbruck、奥地利、6020
      • Linz、奥地利、4010
      • Oberndorf、奥地利、5110
      • Wien、奥地利、1160
      • Wien、奥地利、1090
  • 巴西
      • Brasilia、巴西、70335-000
      • Campinas、巴西、13081-970
      • Campinas、巴西、13012-970
      • Porto Alegre、巴西、90020-090
      • Porto Alegre、巴西、90035-003
      • Ribeirao Preto、巴西、14049-900
      • Rio de Janeiro、巴西、20020-022
      • Santo Andre、巴西、09060-650
      • Sao Luis、巴西、78048-790
      • Sao Paulo、巴西、04040-003
      • Sorocaba、巴西、18047-600
      • Vitoria、巴西、29043-260
  • 德国
      • Berlin、德国、13353
      • Berlin、德国、10969
      • Bonn、德国、53127
      • Düsseldorf、德国、40225
      • Düsseldorf、德国、40237
      • Frankfurt Am Main、德国、60590
      • Freiburg、德国、79106
      • Giessen、德国、35392
      • Hamburg、德国、20099
      • Heidelberg、德国、69120
      • Jena、德国、07747
      • Kiel、德国、24105
      • Köln、德国、50937
      • Mainz、德国、55101
      • München、德国、81675
      • Offenburg、德国、77654
      • Tübingen、德国、72076
      • ULM、德国、89081
  • 比利时
      • Antwerpen、比利时、2650
      • Bruxelles、比利时、1020
      • Bruxelles、比利时、1070
      • Bruxelles、比利时、1000
      • Gent、比利时、9000
      • Kortrijk、比利时、8500
      • Liege、比利时、4000
  • 波多黎各
      • Santurce、波多黎各、00909
  • 澳大利亚
      • Darlinghurst、澳大利亚、2010
      • Fremantle、澳大利亚、6160
      • Melbourne、澳大利亚、3186
      • Nedlands、澳大利亚、6009
      • Sydney、澳大利亚、2139
  • 瑞士
      • Lausanne、瑞士、1005
      • Lugano、瑞士、6903
      • St. Gallen、瑞士、9007
      • Zürich、瑞士、8091
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
    • California
      • La Jolla、California、美国、92037-1030
      • Lancaster、California、美国、93534
      • Long Beach、California、美国、90822
      • Los Angeles、California、美国、90048
      • Los Angeles、California、美国、90057
      • Sacramento、California、美国、95817
      • Sacramento、California、美国、95816
      • San Diego、California、美国、92103-8465
      • Torrance、California、美国、90505
    • Colorado
      • Aurora、Colorado、美国、80045
    • Florida
      • Jacksonville、Florida、美国、32256
      • Orlando、Florida、美国、32803
    • Georgia
      • Atlanta、Georgia、美国、30308
      • Marietta、Georgia、美国、30060
    • Hawaii
      • Honolulu、Hawaii、美国、96813
    • Louisiana
      • Baton Rouge、Louisiana、美国、70890
      • Opelousas、Louisiana、美国、70520
    • Massachusetts
      • Boston、Massachusetts、美国、02114
    • Mississippi
      • Tupelo、Mississippi、美国、38801
    • Missouri
      • St Louis、Missouri、美国、63110
      • St Louis、Missouri、美国、63104
    • New Jersey
      • Egg Harbour Township、New Jersey、美国、08234
      • Hackensack、New Jersey、美国、07601
    • New Mexico
      • Albuquerque、New Mexico、美国、87131
    • New York
      • New York、New York、美国、10016
      • Syracuse、New York、美国、13210
    • North Carolina
      • Asheville、North Carolina、美国、28801
      • Chapel Hill、North Carolina、美国、27599-7080
      • Winston-salem、North Carolina、美国、27103
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112-4481
    • Oregon
      • Portland、Oregon、美国、97239
    • Tennessee
      • Kingsport、Tennessee、美国、37660
    • Texas
      • Fort Sam Houston、Texas、美国、78234-3879
    • Utah
      • Salt Lake City、Utah、美国、84132
    • Virginia
      • Charlottesville、Virginia、美国、22908
      • Fairfax、Virginia、美国、22031
      • Richmond、Virginia、美国、23249

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:

  • adult patients, >=18 years of age;
  • serological evidence of chronic hepatitis C (CHC);
  • CHC genotype 2 or 3;
  • receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
  • compensated liver disease.

Exclusion Criteria:

  • pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
  • coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
  • history or other evidence of decompensated liver disease.

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
实验性的：PEG-IFN alfa-2a + Ribavirin for 24 weeks
After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
药品：利巴韦林
其他名称：
  • 科佩格斯®
药品：聚乙二醇干扰素α-2a
其他名称：
  • 派罗欣®
  • PEG-IFN alfa-2a
有源比较器：PEG-IFN alfa-2a + Ribavirin for 48 weeks
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
药品：利巴韦林
其他名称：
  • 科佩格斯®
药品：聚乙二醇干扰素α-2a
其他名称：
  • 派罗欣®
  • PEG-IFN alfa-2a

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 With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
大体时间：24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.

Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.

Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.
24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment
大体时间：24 weeks after actual end of treatment (range from Week 48 to Week 72).
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.
24 weeks after actual end of treatment (range from Week 48 to Week 72).

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
大体时间：Week 72

Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.

Participants without Week 72 measurements were considered non-responders in the analysis.
Week 72
Percentage of Participants With Virological Response at End of Treatment
大体时间：End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.
End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Percentage of Participants With Virological Relapse
大体时间：End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).

Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.

Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.

Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end.
End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).
Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment
大体时间：12 weeks after actual end of treatment (range from Week 36 to Week 60)
Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.
12 weeks after actual end of treatment (range from Week 36 to Week 60)
Number of Participants With Adverse Events (AEs)
大体时间：From Week 1 through Week 72.
An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above.
From Week 1 through Week 72.

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

Hoffmann-La Roche

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6月1日

初级完成 (实际的)

2012年5月1日

研究完成 (实际的)

2012年5月1日

研究注册日期

首次提交

2008年2月18日

首先提交符合 QC 标准的

2008年2月18日

首次发布 (估计)

2008年2月26日

研究记录更新

最后更新发布 (估计)

2013年7月22日

上次提交的符合 QC 标准的更新

2013年7月15日

最后验证

2013年7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

  • MV21371
  • 2007-004993-15

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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医疗条件

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条件

罕见疾病

药物干预

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赞助者/合作者

地点

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