EUCTR2010-023156-89-BE进行中(未招募)1 期
A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy. - Safety and Efficacy study of V212
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc.0 个研究点目标入组 5,264 人开始时间: 2011年5月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 5,264
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient is =18 years of age with a solid tumor or hematologic malignancy receiving immunosuppressive or cytotoxic chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years (if patient is <30 years old, attended primary or secondary school in a country with endemic VZV infection), is not likely to undergo hematopoietic cell transplant, is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.
- •Patient is =50 years of age with a hematologic malignancy not in remission, may or may not be receiving chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years, is not likely to undergo hematopoietic cell transplant, is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •Patient has a prior history of HZ within 1-year of enrolment, a prior history of receipt of any varicella or zoster vaccine, is likely to undergo hematopoietic cell transplant, and is likely to receive long term antiviral prophylaxis (greater than 4 weeks duration) with activity against varicella-zoster virus zoster, cytomegalovirus, or herpes simplex virus.
研究者
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