Impact of Patient Support From Medical Staff on the Adherence to Therapy With PegIntron Plus Rebetol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 746
- 主要终点
- Number of Participants With Biometrical Adherence to Therapy
研究概览
简要总结
The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management.
The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with chronic hepatitis C.
- •Those participating in patient assistance programs during therapy for hepatitis C.
排除标准
- •Participants who have previously been treatment for hepatitis C (non-naïve)
- •Other exclusion criteria as described in local Summary of Product Characteristics (SPC).
研究组 & 干预措施
All participants
Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
干预措施: PegIntron (Biological)
All participants
Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
干预措施: Rebetol (Drug)
结局指标
主要结局
Number of Participants With Biometrical Adherence to Therapy
时间窗: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3
Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.
Number of Participants With Adherence to Therapy According to Physician Approximation
时间窗: Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3
Adherence was based on physiciant's clinical judgment.
次要结局
未报告次要终点