The Effectiveness of ABT-450/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland (REACH)
2019年5月1日 更新者：AbbVie
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland
The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions.
This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real world conditions in Ireland in a clinical practice patient population.
研究概览
详细说明
This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Ireland.
The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study.
Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites.
Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice.
Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post- treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).
研究类型
观察性的
注册 (实际的)
101
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
取样方法
非概率样本
研究人群
Participants with chronic hepatitis C virus infection, genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin
描述
Inclusion Criteria:
- Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
- If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
- Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
- Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial
Exclusion Criteria:
- None
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
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Participants with HCV genotype 1
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
|
复合片剂
其他名称：
药片
其他名称：
药片
|
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 |
|---|---|---|
|
治疗后 12 周达到持续病毒学应答的参与者百分比 (SVR12)
大体时间：最后一次实际服用研究药物后 12 周
|
SVR12 被定义为在最后一次实际服用研究药物后 12 周丙型肝炎病毒核糖核酸 (HCV RNA) 水平低于 50 IU/mL。 核心人群 (CP) 由满足所有纳入标准并根据护理标准和针对其特定疾病特征（肝硬化状态、基因型）的当地标签建议接受充分治疗的参与者组成。 在研究药物最后一次实际剂量 (CPSFU12) 后 12 周具有足够随访数据的核心人群被定义为满足以下标准之一的所有 CP 参与者：
|
最后一次实际服用研究药物后 12 周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Virologic Response at End of Treatment (EOT)
大体时间：Up to 24 weeks
|
Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.
|
Up to 24 weeks
|
|
Percentage of Participants With Relapse
大体时间：From the end of treatment through the end of study (maximum of 48 weeks post-treatment)
|
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.
|
From the end of treatment through the end of study (maximum of 48 weeks post-treatment)
|
|
病毒突破参与者的百分比
大体时间：长达 24 周
|
病毒突破定义为至少 1 次记录的丙型肝炎病毒核糖核酸（HCV RNA）水平低于 50 IU/mL，随后在治疗期间 HCV RNA 水平大于或等于 50 IU/mL。
|
长达 24 周
|
|
Percentage of Participants With On-treatment Virologic Failure
大体时间：Up to 24 weeks
|
On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).
|
Up to 24 weeks
|
|
Percentage of Participants Meeting Relapse Criteria
大体时间：Up to 12 weeks after the last actual dose of study drug
|
Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.
|
Up to 12 weeks after the last actual dose of study drug
|
|
Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
大体时间：Up to 24 weeks
|
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.
|
Up to 24 weeks
|
|
缺少治疗后 12 周持续病毒学应答 (SVR12) 数据和/或未满足特定 SVR12 无应答者标准的无应答者的百分比
大体时间：最后一次实际服用研究药物后 12 周
|
记录了缺少 SVR12 数据或 SVR12 无应答参与者的数量，这些参与者不符合治疗中病毒学失败、复发、过早停止治疗的标准，并且没有报告病毒学应答不足。
|
最后一次实际服用研究药物后 12 周
|
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
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)
2015年11月5日
初级完成 (实际的)
2017年11月29日
研究完成 (实际的)
2017年11月29日
研究注册日期
首次提交
2015年10月20日
首先提交符合 QC 标准的
2015年10月20日
首次发布 (估计)
2015年10月21日
研究记录更新
最后更新发布 (实际的)
2019年5月6日
上次提交的符合 QC 标准的更新
2019年5月1日
最后验证
2019年4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
- P15-702
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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