A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases (NCT06076642)
Long-term Safety and Tolerability of TAK-881 in Subjects With Primary Immunodeficiency Diseases (PIDD)
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California, Irvine Medical Sciences I β Irvine, California
Age range: 2 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (25 Sites)
- University of California, Irvine Medical Sciences I β Irvine, California
- Allergy & Asthma Clinical Research β Walnut Creek, California
- National Jewish Medical And Research Center β Denver, Colorado
- University of South Florida β St. Petersburg, Florida
- Central Georgia Infectious Disease Consultants β Macon, Georgia
- Rush University Medical Center-Allergy/ Immunology Center β Chicago, Illinois
- Sneeze, Wheeze, & Itch Associates, LLC β Normal, Illinois
- Louisiana State University Health Science Center β New Orleans, Louisiana
- North Shore-Long Island Jewish Health Systems β Great Neck, New York
- Montefiore Medical Center β The Bronx, New York
- Duke Asthma, Allergy and Airway Center β Durham, North Carolina
- Allergy, Asthma and Immunology Center β Tulsa, Oklahoma
- Allergy Partners of North Texas β Dallas, Texas
- University Hospital Brno β Brno,
- Fakultni nemocnice Motol a Homolka Ustav imunologie β Prague,
- Aarhus Universitetshospital β Aarhus,
- General Hospital of Thessaloniki β Thessaloniki,
- Uniwersyteckie Centrum Kliniczne (UCK) β Gdansk,
- Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie β Lodz,
- Wojskowy Instytut Medyczny Panstwowy Instytut β Warsaw,
- Instytut Pomnik - Centrum Zdrowia Dziecka β Warsaw,
- NUDCH (National Institute of Childrens Diseases) β Bratislava,
- OKIA s.r.o β KoΕ‘ice,
- Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK β Martin,
- Hospital Sant Joan de Deu Barcelona β Barcelona,
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Primary Immunodeficiency Diseases (PID) clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.