Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 614
- 主要终点
- Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.
研究概览
简要总结
Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.
详细描述
Enrollment of participants will occur in a sequential order of treatment initiation.
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
- •Adult patients with hepatitis C
排除标准
- •According to the products' labeling
研究组 & 干预措施
PegIntron/Rebetol and psychotherapy support program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
干预措施: Peginterferon alfa-2b (PegIntron) (Biological)
PegIntron/Rebetol and psychotherapy support program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
干预措施: Rebetol (Ribavirin) (Drug)
PegIntron/Rebetol and psychotherapy support program
Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
干预措施: Psychotherapy support program (Behavioral)
PegIntron/Rebetol alone (no psychotherapy)
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
干预措施: Peginterferon alfa-2b (PegIntron) (Biological)
PegIntron/Rebetol alone (no psychotherapy)
Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
干预措施: Rebetol (Ribavirin) (Drug)
结局指标
主要结局
Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.
时间窗: 12 months after onset of treatment
次要结局
- the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol(12 months after onset of treatment)