An Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 221
- 主要终点
- Assess new adverse events, and ongoing adverse events not resolved, in subjects who were exposed to a Investigational Medicinal Product in the 802-247-09-032 trial.
研究概览
简要总结
This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo). This study is being done for the following purposes:
- to identify new adverse events,
- to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-032 trial,
- to record wound status, and
- to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-032 Trial.
About 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.
详细描述
Subjects transitioned to this observational study immediately upon exit from the 802-247-09-032 trial. This ensured a total of 12 months of safety observations and wound status data were obtained from the time of the first application of HP802-247. This study provided consecutive visits at intervals of 8 weeks until a total of 12 months of safety follow-up had been achieved, based on the initial application of Investigational Medicinal Product in the prior study. Specifically, this study examines all new and unresolved ongoing adverse events.
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
- •The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams.
- •Subject was randomized in 802-247-09-032 and received at least one application of test article.
- •Subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion.
排除标准
- •Subjects who refuse to provide written informed consent for this study will be excluded from this study.
结局指标
主要结局
Assess new adverse events, and ongoing adverse events not resolved, in subjects who were exposed to a Investigational Medicinal Product in the 802-247-09-032 trial.
时间窗: Up to 12 months from first application of test article in the 802-247-09-032 study
The evaluation of safety included analysis of new test article-related events, as well as continued follow-up of those adverse events that originated in the prior study.
次要结局
- Follow-up on the status of the target ulcer as open, re-opened or closed.(Up to 12 months from first application of test article in the 802-247-09-032 study)