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A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels

2016年7月5日 更新者：Hoffmann-La Roche

A Quality of Life Study of PEGASYS® (Peginterferon-Alfa2a) in Combination With COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C and Persistently Normal ALT Levels

Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this non-interventional, open-label study. The primary aim is to evaluate quality of life according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the Greek population.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

114

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

  • 希腊
      • Aigaleo - Attiki、希腊、12241
      • Athens、希腊、115 27
      • Athens、希腊、11527
      • Athens、希腊、11528
      • Athens、希腊、11522
      • Athens、希腊、11526
      • Heraklion、希腊、71100
      • Piraeus、希腊、18536
      • Piraeus、希腊、18454
      • Thessaloniki、希腊、546 42

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 CHC and persistently normal ALT levels who have been receiving peginterferon alfa-2a and ribavirin for at least 4 weeks.

描述

Inclusion Criteria:

  • Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay
  • HCV ribonucleic acid (RNA) positive
  • CHC with normal transaminases
  • Compensated liver disease
  • Non-pregnant and willing to use two contraceptive methods (if fertile)
  • At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin

Exclusion Criteria:

  • Pregnant or lactating women
  • Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)
  • History of seizures or depression
  • History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance
  • Uncontrolled thyroid disease
  • Severe retinopathy
  • Leukopenia or thrombocytopenia
  • Bleeding esophageal varices or other evidence of hepatic decompensation

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
Chronic Hepatitis C Participants
Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, will be observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin will be administered as per treating physician discretion and according to summary of product characteristics.
药品：Peginterferon alfa-2a
As per treating physician discretion and according to summary of product characteristics.
其他名称：
  • 飞马座
药品：Ribavirin
As per treating physician discretion and according to summary of product characteristics.
其他名称：
  • 眼镜蛇属

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
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)
大体时间：Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT
大体时间：Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).
Baseline, 24 weeks after EOT (up to 72 weeks)
Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT
大体时间：Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 PCS at 24 Weeks After EOT
大体时间：Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).
Baseline, 24 weeks after EOT (up to 72 weeks)
Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT
大体时间：Baseline, EOT (up to 48 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Baseline, EOT (up to 48 weeks)
Change From Baseline in SF-36 MCS at 24 Weeks After EOT
大体时间：Baseline, 24 weeks after EOT (up to 72 weeks)
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).
Baseline, 24 weeks after EOT (up to 72 weeks)

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

Hoffmann-La Roche

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

2007年2月1日

初级完成 (实际的)

2011年7月1日

研究完成 (实际的)

2011年7月1日

研究注册日期

首次提交

2016年3月29日

首先提交符合 QC 标准的

2016年3月29日

首次发布 (估计)

2016年4月1日

研究记录更新

最后更新发布 (估计)

2016年8月15日

上次提交的符合 QC 标准的更新

2016年7月5日

最后验证

2016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

  • ML20151

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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医疗条件

药物干预

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条件

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