Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT06955793
Eligibility Criteria:
Inclusion Criteria:
1. Participant has PIDD and has completed the end-of-study visit of Study TAK-881-3002.
2. Participant is demonstrating continued benefit from TAK-881 for the treatment of PIDD in the opinion of the treating physician.
3. Participant, or (in the case of minors) legally designated representative(s) is/are informed of the nature of the expanded access program and can provide written informed consent/assent (if applicable), including providing consent/assent for use of the investigational medical device, before initiation of any program procedures.
4. Participant does not have any condition, including laboratory test result, that in the opinion of the treating physician may compromise the participant's safety.
5. Participant does not have a known hypersensitivity to TAK-881 or its components.
Exclusion Criteria:
1. 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.
2. Participant is pregnant or lactating or intends to become pregnant or begin lactating during the program.
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT06955793
Study Brief:
Protocol Section:
NCT06955793