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Expanded Access to TAK-881 for Children and Teenagers With Primary Immunodeficiency Diseases in the USA

NCT06955793 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-05-02

No results posted yet for this study

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.), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.

Conditions

  • Primary Immunodeficiency Diseases (PIDD)

Interventions

BIOLOGICAL

TAK-881

Participants will receive SC infusion of TAK-881.

DEVICE

SC Investigational Needle Sets

The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955793 on ClinicalTrials.gov