An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy (PEGHOPE)
2017年3月10日 更新者：Hoffmann-La Roche
A Prospective, Observational, Multicenter Non-interventional Trial Examining Efficacy of Combination Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD) Plus COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing an Opioid Maintenance-Therapy With Special Focus on Patient Compliance and Quality of Life
This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy.
Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
88
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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Gratwein、奥地利、8112
- Lkh Hoergas-Enzenbach; Abt. Für Innere Medizin
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Graz、奥地利、8036
- LKH-Univ. Klinikum Graz
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Innsbruck、奥地利、6020
- Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
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Klagenfurt、奥地利、9020
- Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
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Linz、奥地利、4010
- A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.
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Wien、奥地利、1090
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
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Wien、奥地利、1030
- Gesundheitszentrum Wien Mitte
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Wien、奥地利、1030
- Krankenanstalt Rudolfstiftung; Iv. Med. Abtl.
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Wien、奥地利、1100
- Kaiser Franz Josef Spital; Iv. Medizinische Abt.
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Wien、奥地利、1160
- Wilhelminenspital; 6. Medizinische Abteilung Wilhelminenspital; 6. Medizinische Abteilung
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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
概率样本
研究人群
Participants with chronic hepatitis C (CHC), Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
描述
Inclusion Criteria:
- Adult participants, >/= 18 years of age
- Participants undergoing an opioid maintenance therapy
- Serologic evidence of CHC prior to therapy
- CHC genotype 2, 3, 1 or 4
- Quantifiable serum hepatitis C (HCV) ribonucleic acid (RNA)
- All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment
Exclusion Criteria:
- Harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator
- Pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study
- Co-infection with hepatitis A, hepatitis B or Human Immunodeficiency Virus (HIV)
- Current diagnosis of a major depression or any psychotic disorder
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 |
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All Participants
Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
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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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Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)
大体时间：24 weeks after completing treatment, within 3 years, 6 months
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SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach.
Percentage is based on the number of non-missing observations (total).
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24 weeks after completing treatment, within 3 years, 6 months
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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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Percentage of Participants With SVR 12
大体时间：12 weeks after completing treatment, within 3 years, 6 months
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SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach.
Percentage is based on the number of non-missing observations (total).
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12 weeks after completing treatment, within 3 years, 6 months
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Percentage of Participants With End of Treatment Response
大体时间：at end of treatment, within 3 years, 6 months
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A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach.
Percentage is based on the number of non-missing observations (total).
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at end of treatment, within 3 years, 6 months
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Percentage of Participants With Virological Relapse
大体时间：by end of follow-up, within 3 years, 6 months
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Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach.
Percentage is based on the number of non-missing observations (total).
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by end of follow-up, within 3 years, 6 months
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Short Form Health Survey (SF-36) Scores by Visit
大体时间：at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide.
Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best).
Summary SF-36 scores are reported by category and by visit.
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at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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Fatigue Severity Scale (FSS) Score by Visit
大体时间：at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life.
The FSS score is the mean of the 9 numbers.
Mean scores are presented by visit.
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at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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Beschwerdeliste (BL) Score by Visit
大体时间：at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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The BL questionnaire items were scored by calculating the average response to all answered items.
Items can be graded 1="stark" (affliction is strong) to 4="gar nicht" (not present).
The higher the BL score, the less afflictions were present for a participant.
Mean scores are presented by visit.
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at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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Beck Depression Inventory (BDI) Score by Visit
大体时间：at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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The BDI questionnaire items were scored by generating the sum of the responses to all answered items.
Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression.
Mean scores are presented by visit.
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at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
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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。
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。
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
2010年4月1日
初级完成 (实际的)
2014年10月1日
研究完成 (实际的)
2014年10月1日
研究注册日期
首次提交
2011年8月12日
首先提交符合 QC 标准的
2011年8月12日
首次发布 (估计)
2011年8月15日
研究记录更新
最后更新发布 (实际的)
2017年4月10日
上次提交的符合 QC 标准的更新
2017年3月10日
最后验证
2017年3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.
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Meir Medical Center完全的开发从数字立体光盘图像测量 C/D 比的新技术 | C/D 测量的观察者内再现性 | C/D 测量的观察者间变异性
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University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
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Haisco Pharmaceutical Group Co., Ltd.完全的