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Long-term Safety and Tolerability of TAK-881 in Subjects with Primary Immunodeficiency Diseases (PIDD)
EU CTIS ID: 2023-505946-24-00
What this study is testing
To evaluate the long-term safety and tolerability of TAK-881 in all subjects
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has completed Study TAK-881-3001.
- Subject or, in the case of minors, legally designated representative(s) is/are willing and able to comply with the requirements of the protocol.
- The subject or, in the case of minors, legally designated representative(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medicinal device (in US sites only), prior to the initiation of any study procedures.
You likely can't join if
- 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 was enrolled in another clinical study involving an 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.
- Subjects with potential to become pregnant who meet any one of the following criteria: a. Subject has a positive pregnancy test. b. Subject does not agree to employ a highly effective form of contraception for the duration of the study.
See the full eligibility criteria
- Has completed Study TAK-881-3001.
- Subject or, in the case of minors, legally designated representative(s) is/are willing and able to comply with the requirements of the protocol.
- The subject or, in the case of minors, legally designated representative(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medicinal device (in US sites only), prior to the initiation of any study procedures.
- 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 was enrolled in another clinical study involving an 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.
- Subjects with potential to become pregnant who meet any one of the following criteria: a. Subject has a positive pregnancy test. b. Subject does not agree to employ a highly effective form of contraception for the duration of the study.
- Subject is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.