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临床试验/NCT01773070
NCT01773070已完成3 期

A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

AbbVie (prior sponsor, Abbott)0 个研究点目标入组 478 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
478
主要终点
Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection

研究概览

简要总结

A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND.
  • The interval between the last dose of the AbbVie DAA therapy from the previous clinical study and enrollment in Study M13-102 must be no longer than 2 years.
  • The subject must voluntarily sign and date the informed consent form.
  • Subject completed the post-treatment period of an eligible prior study.

排除标准

  • The investigator considers the subject unsuitable for the study for any reasons.
  • Receipt of any investigational product from Day 1 and while enrolled in this study.

研究组 & 干预措施

All Participants

Other

Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.

干预措施: ABT-450/ritonavir (Drug)

All Participants

Other

Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.

干预措施: ABT-333 (Drug)

All Participants

Other

Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.

干预措施: ABT-267 (Drug)

结局指标

主要结局

Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection

时间窗: Up to 3 years post-treatment

Relapse is defined as a confirmed HCV ribonucleic acid (RNA) ≥ the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA ≥ LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA \< LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.

Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B

时间窗: from the last dose of study drug in the previous study up to 3 years post-treatment

The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in participants who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.

次要结局

  • Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection(From the end of treatment through 12 weeks post-treatment)
  • Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection(From the end of treatment through 24 weeks post-treatment)
  • Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection(Up to 3 years post-treatment)

研究者

发起方
AbbVie (prior sponsor, Abbott)
申办方类型
Industry
责任方
Sponsor

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