Expanded Access to TAK-881 for People With Primary Immunodeficiency Diseases in the USA and Czech… (NCT06955793) | Clinical Trial Compass
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Expanded Access to TAK-881 for People With Primary Immunodeficiency Diseases in the USA and Czech Republic
Plain-language summary
The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This study will provide access to TAK-881 for participants with PIDD who have completed study TAK-881-3002 \[NCT06076642\], who continue to derive clinical benefit from maintenance treatment with TAK-881 and wish to continue this treatment.
All participants will receive TAK-881 as subcutaneous (SC) injection using a qualified medical device (Koru 24 G HIgH Flo Subcutaneous Safety Needle Set) that will be individualized for each participant, at the treating physician's discretion and dependent on serum IgG trough level and clinical response.
Participants will continue treatment until the benefit-risk no longer favors the participant or TAK-881 becomes commercially available in the United States (U.S.) and Czech Republic (the device is approved), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant has PIDD and has completed the end-of-study visit of Study TAK-881-3002.
. Participant is demonstrating continued benefit from TAK-881 for the treatment of PIDD in the opinion of the treating physician.
. Participant, or (in the case of minors) legally designated representative(s) is/are informed of the nature of this program and can provide written informed consent/assent (if applicable).
. Participant does not have any condition, including laboratory test result, that in the opinion of the treating physician may compromise the participant's safety.
. Participant does not have a known hypersensitivity to TAK-881 or its components.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Participant has potential to become pregnant and the participant does not agree to employ a highly effective form of contraception for the duration of the program.
. Participant is pregnant or lactating or intends to become pregnant or begin lactating during the program.