Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C
研究概览
简要总结
Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.
详细描述
Non-Probability Sample, Commercial product used according to EU label.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •According to PegIntron/Rebetol label.
- •Only HCV genotype 1 infected patients will be enrolled in the study.
排除标准
- •According to PegIntron/Rebetol label.
研究组 & 干预措施
Treatment and Patient Assistance Program
Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
干预措施: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
Treatment and Patient Assistance Program
Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
干预措施: Rebetol (ribavirin; SCH 18908) (Drug)
Treatment and Patient Assistance Program
Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
干预措施: Patient Assistance Program (Behavioral)
Treatment Alone
PegIntron/Rebetol treatment only.
干预措施: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
Treatment Alone
PegIntron/Rebetol treatment only.
干预措施: Rebetol (ribavirin; SCH 18908) (Drug)
结局指标
主要结局
The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C
时间窗: At the end of the 48-week treatment period
Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program
The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment
时间窗: Measured at 6 months post-treatment
Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment
The Number of Participants Who Relapsed at 6 Months Post-treatment
时间窗: Measured at end of treatment and 6 months post-treatment
Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment
次要结局
- Average Length of Treatment(Maximum 48-week treatment duration)
- Average Dosage of PegIntron(Up to 48-week treatment duration)
- Average Dosage of Rebetol(Up to 48-week treatment duration)