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An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

2018年11月21日 更新者：Hoffmann-La Roche

Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

991

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

  • 以色列
      • Afula、以色列、18101
        • Haemek Hospital; Gastroenterology
      • Ashkelon、以色列、78278
        • Barzilai MC; Gastroenterology
      • Beer Sheva、以色列、84105
        • Soroka Medical Center; Gastroenterology
      • Hadera、以色列、38100
        • Hillel Yaffe Hospital; Gastroenterology
      • Haifa、以色列、31096
        • Rambam Medical Center; Gastroenterology - Liver Unit
      • Haifa、以色列、33394
        • Bnei-Zion Medical Center; Gastroenterology
      • Haifa、以色列、34362
        • Carmel Hospital; Liver Unit
      • Holon、以色列、58100
        • Wolfson Hospital; Gastroenterology Unit
      • Jerusalem、以色列、91031
        • Shaare Zedek Hospital Liver Unit; Liver Unit
      • Jerusalem、以色列、91120
        • Hadassah Hospital; Liver Unit
      • Kfar Saba、以色列、44281
        • Meir Medical Center; Liver Unit
      • Nahariya、以色列、22100
        • Western Galilee Hospital - Nahariya
      • Nazareth、以色列
        • Holy Family Medical Center; Liver Unit
      • Petach Tikva、以色列
        • Hasharon Mc; Gastroenterology
      • Petah Tiqwa、以色列
        • Beilinson-Rabin Liver Unit; Liver Unit
      • Ramat Gan、以色列、5262100
        • Sheba Medical Center; Tel Hashomer
      • Rehovot、以色列、76100
        • Kaplan Medical Center; Gastroenterology Unit
      • Safed、以色列、13110
        • Rebecca Sieff Medical Center; Liver Unit
      • Tel Aviv、以色列、6423906
        • Tel-Aviv Sourasky Medical Center; Liver Unit
      • Tiberias、以色列
        • Poria Hospital; Gastroenterology
      • Zerifin、以色列、6093000
        • Assaf Harofeh; Gastroenterology

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

Chronic hepatitis C patients initiating Pegasys-based treatment

描述

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
  • Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
  • No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
  • Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion Criteria:

  • Hepatitis A/B co-infection
  • Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Pregnant or breast-feeding women

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：队列
  • 时间观点：预期

队列和干预

团体/队列
队列

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
Percentage of Participants With Sustained Viral Response (SVR) at Week 24
大体时间：Week 24
The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.
Week 24

次要结果测量

结果测量
措施说明
大体时间
Comparison of SVR at Week 24
大体时间：Week 24
SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.
Week 24
Number of Participants With SVR at Week 24 According to the Demographic Characteristics
大体时间：Week 24
The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.
Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
大体时间：Week 4
RVR was defined as HCV-RNA <50 IU/mL by Week 4
Week 4
Percentage of Participants With Extended RVR
大体时间：Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group

Extended RVR was defined as HCV-RNA <50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 & 24 for participants treated with boceprevir.

The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.
Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group
Percentage of Participants With Complete Early Virologic Response (cEVR)
大体时间：Week 12
Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12
Week 12
Percentage of Participants With End of Treatment Response (EoT)
大体时间：Week 24
End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment.
Week 24
Percentage of Participants With Virologic Relapse
大体时间：Week 72
Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA <50 IU/mL at EoT.
Week 72
Treatment Duration
大体时间：Week 48
The average amount of time a treatment was prescribed to participants.
Week 48
Time to First Dose Modification of Peginterferon Alfa-2a
大体时间：Week 48
Week 48
Time to First Dose Modification of Ribavirin
大体时间：Week 48
Week 48
Time to First Dose Modification of Telaprevir/Boceprevir
大体时间：Week 48
Week 48
Percentage of Participants With Adverse Events (AEs)
大体时间：Week 48

Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.
Week 48
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia
大体时间：Week 48
Week 48
Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia
大体时间：Week 48
Week 48
Percentage of Participants Who Had SVR at Week 24 With Dose Modifications
大体时间：Week 24
Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.
Week 24

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

合作者

Clalit Health Services

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)

2012年5月28日

初级完成 (实际的)

2016年2月10日

研究完成 (实际的)

2016年2月10日

研究注册日期

首次提交

2012年5月21日

首先提交符合 QC 标准的

2012年5月21日

首次发布 (估计)

2012年5月23日

研究记录更新

最后更新发布 (实际的)

2019年3月14日

上次提交的符合 QC 标准的更新

2018年11月21日

最后验证

2018年11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

  • ML28268

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

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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