A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir
2016年2月19日 更新者：Janssen Scientific Affairs, LLC
A Prospective Observational Study to Examine Patient Characteristics, Health Care Management, and Effectiveness Among HCV Patients Treated With Simeprevir at Various Practice Settings
The purpose of this study is to evaluate the effectiveness of a simeprevir-containing hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).
研究概览
详细说明
This is a multicenter, observational (a study in which the investigators/ physicians observe the patients and measure their outcomes), prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study) designed to reflect routine clinical practice.
Approximately 300 Hepatitis C virus (HCV) infected patients who are prescribed simeprevir by their health care provider as part of their routine HCV treatment regimen, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled in this and observed to evaluate the effectiveness of a simeprevir.
Practice setting features will be documented at the initiation of the study by each participating site.
The decision of patients to participate in this study will in no way impact upon the standard of care that they are receiving.
All treatment decisions will be made at the discretion of the health care provider.
Safety assessments will include assessment of adverse events, and clinical laboratory parameters (hematology, clotting tests, human immunodeficiency virus tests, chemistry, and liver function tests).
The maximum study duration for each patient will be approximately 2 years.
研究类型
观察性的
注册 (实际的)
315
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
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Arizona
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Phoenix、Arizona、美国
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California
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Bakersfield、California、美国
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Beverly Hills、California、美国
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Los Angeles、California、美国
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Florida
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Daytona Beach、Florida、美国
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Deland、Florida、美国
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Miami、Florida、美国
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Tampa、Florida、美国
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West Palm Beach、Florida、美国
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Kentucky
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Crestview Hills、Kentucky、美国
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Maryland
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Baltimore、Maryland、美国
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Massachusetts
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Springfield、Massachusetts、美国
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New Jersey
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Newark、New Jersey、美国
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Vineland、New Jersey、美国
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New York
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Brooklyn、New York、美国
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Flushing、New York、美国
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New York、New York、美国
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Ny、New York、美国
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North Carolina
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Durham、North Carolina、美国
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Fayetteville、North Carolina、美国
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Rocky Mount、North Carolina、美国
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Statesville、North Carolina、美国
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Winston Salem、North Carolina、美国
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Ohio
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Cincinnati、Ohio、美国
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Pennsylvania
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Doylestown、Pennsylvania、美国
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Philadelphia、Pennsylvania、美国
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Tennessee
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Nashville、Tennessee、美国
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Texas
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Austin、Texas、美国
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Dallas、Texas、美国
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Fort Worth、Texas、美国
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Houston、Texas、美国
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Utah
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Murray、Utah、美国
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Virginia
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Norfolk、Virginia、美国
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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
Hepatitis C virus (HCV) infected patients receiving simeprevir.
描述
Inclusion Criteria:
- Patients who have genotype 1 chronic hepatitis C infection
- Hepatitis C virus (HCV) ribonucleic acid (RNA) test result above the limit of quantification before initiation of simeprevir-based therapy
- Health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled into the study
- Prior HCV treatment must be completed more than 3 months before initiation of simeprevir-based therapy
- In the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine
Exclusion Criteria:
- Non-genotype 1 HCV infected patients
- Absolute contraindication to any component of prescribed HCV treatment per prescribing information
- Patient is currently enrolled in an interventional study
- Past use of an HCV direct-acting antiviral therapy
- Any investigational drug use within 30 days before initiation of simeprevir-based therapy
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
队列和干预
团体/队列 |
干预/治疗 |
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Hepatitis C virus infected patients receiving simeprevir
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This is an observational study.
Patients receiving simeprevir (single capsule of 150 mg once daily) as prescribed by the health care provider will be observed.
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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 |
|---|---|---|
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Number of Patients who Achieve Sustained Virologic Response(SVR)
大体时间：12 weeks after the actual end of treatment (an expected average of up to 2 years)
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SVR is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at least 12 weeks after the actual end of all HCV treatment.
Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Determination of Prognostic Factors of Virologic Response
大体时间：12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Prognostic factors of virologic response includes patient and disease characteristics, treatment paradigm, Rapid Virologic Response (RVR), and select practice setting features.
Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Total duration of therapy
大体时间：Up to actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Discontinue Therapy by reason
大体时间：Up to actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Achieve Rapid Virologic Response (RVR)
大体时间：Week 4
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RVR is defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
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Week 4
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Number of Patients who Achieve Sustained Virologic Response(SVR) Among Participants who Achieve Rapid Virologic Response (RVR)
大体时间：12 weeks after the actual end of treatment (an expected average of up to 2 years)
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SVR is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at least 12 weeks after the actual end of all HCV treatment.
RVR is defined as undetectable HCV RNA at Week 4. Actual end of treatment will be determined by health care provider.
Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Achieve Sustained Virologic Response(SVR) According to Patient Demographics, Baseline Disease Characteristics, Treatment Paradigm, and Select Practice Setting Features
大体时间：12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With On-treatment Virologic Failure
大体时间：Up to actual end of treatment (an expected average of up to 2 years)
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On-treatment virologic failure is defined as a confirmed increase of >1 log10 IU/mL in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in patients whose HCV RNA had previously been <25 IU/mL.
Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Viral Relapse
大体时间：Up to actual end of treatment (an expected average of up to 2 years)
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Viral Relapse is defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) after concluding treatment with undetectable HCV RNA.
Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Adverse Events by Grade and Causality
大体时间：Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Changes in Clinical Laboratory Parameters by Grade and Causality
大体时间：Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Adverse Event Determined to be Related to Simeprevir
大体时间：Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Serious Adverse Event
大体时间：Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Develop Mutations at the Time of Virologic Failure
大体时间：Up to actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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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。
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
2014年2月1日
初级完成 (实际的)
2015年11月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2014年2月18日
首先提交符合 QC 标准的
2014年4月1日
首次发布 (估计)
2014年4月4日
研究记录更新
最后更新发布 (估计)
2016年2月22日
上次提交的符合 QC 标准的更新
2016年2月19日
最后验证
2016年2月1日
更多信息
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.