ong-term Safety and Tolerability of TAK-881 in Subjects with Primary Immunodeficiency Diseases (PIDD) - TAK-881-3002

Takeda Development Center Americas Inc.0 个研究点目标入组 39 人开始时间: 2023年11月6日最近更新: 2024年8月21日

适应症

试验速览

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•Has completed Study TAK-881-3001., If female of childbearing potential, the subject presents with a negative pregnancy test at screening and agrees to employ a highly effective form of contraception for the duration of the study., Subject/legally authorized representative is willing and able to comply with the requirements of the protocol.

•Subject has a serious medical condition such that the subject’s safety or medical care would be impacted by participation in this long-term follow-up study., New medical condition that developed during participation in Study TAK-881-3001 that, in the judgment of the investigator, could increase risk to the subject or interfere with the evaluation of TAK-881 and/or conduct of the study., Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening (with the exception of Study TAK-881-3001)., Subject is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study., Subject is a family member or employee of the investigator or the investigator’s site staff., If female, subject is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.

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