EUCTR2008-008124-33-GB进行中（未招募）1 期
A phase IIIb, open, multi centre gynaecological extension study for follow-up of a subset of 580299/008 study subjects who were either cervical cytology negative and oncogenic HPV positive or pregnant at their final 580299/008 study visit (Visit 10 at Month 48). - HPV-052 EXT 008
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,022
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
- Female
入选标准
- •Written informed consent obtained from the subject prior to enrolment.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- •A subject previously enrolled in the study HPV-008 and who fulfils either of the following criteria:
- •displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last HPV-008 study visit (Visit 10, Month 48).
- •or was pregnant at her last visit of the HPV-008 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last HPV-008 study visit (Visit 10, Month 48).
- •A subject who had a cervical lesion at her last HPV-008 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the HPV-008 exit colposcopy.
- •A subject for whom the cervical cytology results from the last HPV-008 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.
研究者
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