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TAK-881-3002
Recruiting

A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases

Clinicaltrials.gov
#NCT06076642
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About this clinical trial

The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035). The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval (can be adjusted by participant/caregiver) and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits. Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.

US
Interventional Phase 3 clinical trial.

At a glance

What medical conditions are being studied?

Primary Immunodeficiency Diseases (PID)

What is the clinical trial testing?

TAK-881, SC Investigational Needle Sets

How many participants are being enrolled?

39

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Nov 2024 - Jan 2029

How long is participation in the clinical trial?

Participants will stay in the study for up to 129 weeks.

Key requirements

Sexes

All

Age

2+ Years

Healthy volunteers?

No

Entry criteria

Must have completed Study TAK-881-3001
Cannot have a serious medical condition.
Cannot have a new medical condition developed during Study TAK-881-3001 that could increase risk or interfere with the evaluation of the study product and/or conduct of the study, in the study doctor’s judgment.
Cannot be pregnant or lactating.
Additional entry criteria will be discussed with the study doctor.

Locations

Recruiting
Recruiting