NCT02581020已完成不适用
A Follow-up Study to Assess the Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
AbbVie53 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2016年1月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 53
- 主要终点
- Hepatitis C virus ribonucleic acid (HCV RNA) levels
研究概览
简要总结
This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement.
- •Participants who agree to sign the informed consent
排除标准
- •Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.
结局指标
主要结局
Hepatitis C virus ribonucleic acid (HCV RNA) levels
时间窗: 60 months after completion of the 2D treatment in M12-536 or M13-004 study
HCV RNA levels in plasma
次要结局
- Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A)(For approximately 5 years)
- Number of participants with serious adverse events (SAEs)(Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study)
- Hepatitis C virus ribonucleic acid (HCV RNA) levels(18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study)
- Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3)(For approximately 5 years)
- Percentage of participants with hepatocellular carcinoma(Up to 60 month after completion of the 2D treatment in M12-536 or M13-004)
研究者
研究点 (53)
Loading locations...
相似试验
已完成
2 期
A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530Hepatitis CNCT02441283AbbVie384
已完成
3 期
A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C StudyHepatitis CNCT01773070AbbVie (prior sponsor, Abbott)478
终止
不适用
A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy VolunteersGroup B Streptococcus InfectionNCT06280157Minervax ApS29
终止
3 期
A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) InfectionHepatitis CNCT03099135Janssen Research & Development, LLC24
已完成
不适用
Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) VaccineInfections, CytomegalovirusNCT01357915GlaxoSmithKline47