Clinical Research Directory

Expanded Access to TAK-881 for People With Primary Immunodeficiency Diseases in the USA and Czech Republic

Sponsor: Takeda

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.

Official title: Expanded Access Program for United States of America: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD); Specific Therapeutic Program for Czech Republic: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD)

Key Details

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Interventions