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临床试验/NCT00723632
NCT00723632已完成不适用

Cost of Treatment of Chronic Hepatitis C Using Combination of Peginterferon α-2b Plus Ribavirin

Merck Sharp & Dohme LLC0 个研究点目标入组 901 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
901
主要终点
Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category

研究概览

简要总结

The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with chronic hepatitis C
  • At least 18 years old
  • Eligibility determined based on the diagnosis and medical judgment only.

排除标准

  • 未提供

研究组 & 干预措施

Peginterferon alfa-2b and ribavirin

All participants included in the study

干预措施: peginterferon alfa-2b (Biological)

Peginterferon alfa-2b and ribavirin

All participants included in the study

干预措施: ribavirin (Drug)

结局指标

主要结局

Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category

时间窗: From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3

SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.

次要结局

  • Average Cost Per Participant With SVR Stratified by Ribavirin Dosage(From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3)
  • Average Cost Per Participant With SVR Stratified by Prior Treatment Status(From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3)

研究者

申办方类型
Industry
责任方
Sponsor

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