NL-OMON56419招募中3 期
EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC CHILDREN (EPOPEX) - EPOPEX
/0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 11（—）
入选标准
- •All subjects who completed the EPITOPE study up to Visit 11 (inclusive) will be
- •offered enrollment into the EPOPEX study, provided that all selection criteria
- •are met. Subjects will be enrolled in this study only if they meet, among
- •others, the following key inclusion criteria: completion of the EPITOPE study,
- •with a completed and documented DBPCFC at Month 12 (i.e., both Visit 10 and
- •Visit 11 performed).
排除标准
- •Subjects will not be enrolled, if they meet, among others, the following
- •exclusion criteria: development of severe anaphylactic reaction during the
- •Month 12 DBPCFC (at Visit 10 or Visit 11) in the EPITOPE study requiring a
- •tracheal intubation or leading to a cardiac arrest and/or to coma; other cases
- •of severe anaphylaxis will be considered eligible to enter the EPOPEX study.
研究者
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