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临床试验/NCT00723710
NCT00723710已完成不适用

Guidelines to the Intron A® Health Management Program II: A Nursing Support Program for Patients With High-Risk Melanoma Receiving High Dose Intron A Therapy

Merck Sharp & Dohme LLC0 个研究点目标入组 299 人开始时间: 2006年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
299
主要终点
Number of Participants Who Completed Treatment

研究概览

简要总结

Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.

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

  • Signed informed consent
  • Age > 18 years
  • Confirmed melanoma
  • Patient has been prescribed Intron A therapy for High-Risk Stage II & III Melanoma
  • Intron A therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval)
  • Proper contraception in both male and female subjects and the female partner(s) of male study subjects

排除标准

  • Metastatic disease at the time of diagnosis
  • Other malignancies
  • History of non compliance to other therapies
  • Pregnancy or breast feeding
  • Previous Intron A therapy

结局指标

主要结局

Number of Participants Who Completed Treatment

时间窗: Up to 1 year

Treatment completion was defined as those who completed both the induction and maintenance phases.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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