Status:
AVAILABLE
Expanded Access to TAK-881 for Children and Teenagers With Primary Immunodeficiency Diseases in the USA
Lead Sponsor:
Takeda
Conditions:
Primary Immunodeficiency Diseases (PIDD)
Eligibility:
All Genders
2+ years
Brief 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 st...
Eligibility Criteria
Inclusion
- 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 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.
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06955793
Last Update
May 2 2025
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