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Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia (MAGNITUDE)

2020年8月7日 更新者：Bristol-Myers Squibb

A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin

The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3

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)

71

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

  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、107996
        • Local Institution
      • Saint Petersburg、俄罗斯联邦、191186
        • Local Institution
  • 意大利
      • Firenze、意大利、50134
        • Local Institution
      • Milan、意大利、20122
        • Local Institution
      • Roma、意大利、00185
        • Local Institution
      • Torino、意大利、10126
        • Local Institution
  • 法国
      • Grenoble、法国、38043
        • Local Institution
      • Lyon Cedex 04、法国、69317
        • Local Institution
      • Montpellier Cedex 5、法国、34295
        • Local Institution
      • Paris Cedex 13、法国、75651
        • Local Institution
      • Paris Cedex 14、法国、75679
        • Local Institution
      • Vandoeuvre Les Nancy、法国、54511
        • Local Institution
  • 澳大利亚
      • Herston、澳大利亚、4029
        • Local Institution
    • New South Wales
      • Camperdown、New South Wales、澳大利亚、2050
        • Local Institution
    • Queensland
      • Herston、Queensland、澳大利亚、4029
        • Local Institution
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Local Institution
    • Victoria
      • Melbourne、Victoria、澳大利亚、3004
        • Local Institution
  • 罗马尼亚
      • Bucuresti、罗马尼亚、50524
        • Local Institution
      • Constanta、罗马尼亚、900635
        • Local Institution
      • Iasi、罗马尼亚、700506
        • Local Institution
      • Iasi、罗马尼亚、700116
        • Local Institution
  • 美国
    • California
      • Palo Alto、California、美国、94304
        • Stanford Boswell Clinic
    • Illinois
      • Chicago、Illinois、美国、60612
        • Rush University Medical Center
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Hospital of the University of Pennsylvania
    • Utah
      • Murray、Utah、美国、84123
        • Clinical Research Centers Of America
  • 荷兰
      • Amsterdam、荷兰、1105 AZ
        • Local Institution
      • Nijmegen、荷兰、6525 GA
        • Local Institution
      • Rotterdam、荷兰、3015 CE
        • Local Institution
      • Utrecht、荷兰、3508 GA
        • Local Institution
  • 西班牙
      • Barcelona、西班牙、08035
        • Local Institution
      • Madrid、西班牙、28046
        • Local Institution
      • Sevilla、西班牙、41013
        • Local Institution

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

男性

描述

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Severe hemophilia (defined as < 1% factor activity level)
  • Infection with the hepatitis C virus (HCV) with underlying hemophilia
  • Males 18 years of age and above
  • Have not been previously treated with an interferon

Exclusion Criteria:

  • Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Chronic liver disease caused by any disease other than chronic HCV infection
  • Presence of Bethesda inhibitor
  • Current evidence of or history of portal hypertension

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：非随机化
  • 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：Cohort A: Genotype-2,-3 (Lambda/RBV/DCV)

Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks

Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks

Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
药品：利巴韦林
药品：达卡他韦
其他名称：
  • BMS-790052
生物：Pegylated-Interferon-lambda
其他名称：
  • BMS-914143
  • pegIFNλ
实验性的：Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)

Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks

Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks

Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
药品：利巴韦林
药品：达卡他韦
其他名称：
  • BMS-790052
生物：Pegylated-Interferon-lambda
其他名称：
  • BMS-914143
  • pegIFNλ

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 Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12
大体时间：Follow-up Week 12
SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
Follow-up Week 12

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Rapid Virologic Response (RVR)
大体时间：Treatment Week 4
RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.
Treatment Week 4
Percentage of Participants With Complete Early Virologic Response (cEVR)
大体时间：Treatment Week 12
cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.
Treatment Week 12
Percentage of Participants With End of the Treatment Response (EOTR)
大体时间：End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)
EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.
End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)
Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)
大体时间：Follow-up Week 24
SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.
Follow-up Week 24
Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment
大体时间：After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) <10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) <750 mm^3, and/or thrombocytopenia: platelets <50,000 mm^3.
After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment
大体时间：After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.
After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
大体时间：From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.
From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
大体时间：After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): >2.0*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : >5*ULN; Aspartate aminotransferase (AST): >5*ULN; Prothrombin Time (PT): >1.50*ULN; Bilirubin (Total): >2.5*ULN; Triglycerides (fasting): >750 mg/dL.
After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

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

Bristol-Myers Squibb

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。

有用的网址

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 (实际的)

2013年3月31日

初级完成 (实际的)

2015年1月31日

研究完成 (实际的)

2015年1月31日

研究注册日期

首次提交

2012年12月3日

首先提交符合 QC 标准的

2012年12月3日

首次发布 (估计)

2012年12月5日

研究记录更新

最后更新发布 (实际的)

2020年8月11日

上次提交的符合 QC 标准的更新

2020年8月7日

最后验证

2020年8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

  • AI452-030
  • 2012-003463-22 (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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