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A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
Sponsor: Takeda
Summary
The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16 years old and older. The participants will be treated with TAK-881/HYQVIA or HYQVIA/TAK-881 with the same dose and dosing interval of immunoglobulin for up to 51 weeks (for participants greater than or equal to \[\>=\]16 years) and only with TAK-881 for up to 27 weeks (for participants aged 2 to less than \[\<\]16 years) as they were treated with another immunoglobulin before enrollment. Participants will need to visit the clinic every 3 or 4 weeks during the duration of the study.
Official title: Multicenter, Prospective, Open-label, Randomized, Crossover Study to Evaluate Pharmacokinetics (PK), Safety, and Tolerability of TAK-881 in Primary Immunodeficiency Diseases (PIDD)
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2023-10-24
Completion Date
2026-01-20
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
TAK-881
Participants will receive SC infusion of TAK-881.
HYQVIA
Participants will receive SC infusion of HYQVIA.
Locations (32)
University of California Irvine Medical Center
Irvine, California, United States
Allergy and Asthma Clinical Research
Walnut Creek, California, United States
National Jewish Medical And Research Center
Denver, Colorado, United States
University of South Florida
St. Petersburg, Florida, United States
Central Georgia Infectious Disease Consultants
Macon, Georgia, United States
Rush University Medical Center - University Cardiovascular Surgeons
Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, United States
Louisiana State University Health Science Center-New Orleans
New Orleans, Louisiana, United States
Northwell Health
Great Neck, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, United States
Optimed Research, LTD
Columbus, Ohio, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Allergy Partners of North Texas
Dallas, Texas, United States
Tanner Clinic
Murray, Utah, United States
University Hospital Brno (Fakultni Nemocnice Brno) - Children's Hospital (Detska nemocnice)
Brno, Czechia
Fakultni nemocnice u sv. Anny v Brne - ICRC
Brno, Czechia
Fakultni Nemocnice v Motole
Prague, Czechia
Aarhus Universitetshospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark
University Hospital Carl Gustav Carus
Dresden, Germany
Universitaetsklinikum Tuebingen (UKT)
Tübingen, Germany
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, Netherlands
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, Poland
Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne, KLINIKA PEDIATRII, HEMATOLOGII I ONKOLOGII
Gdansk, Pomeranian Voivodeship, Poland
Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie Wielospecjalistyczne Centrum i Traumatologii im. M. Kopernika w Lodzi
Lodz, Poland
NUDCH (National Institute of Children's Diseases)
Bratislava, Slovakia
OKIA, s.r.o
Košice, Slovakia
Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK Martin
Martin, Slovakia
Hospital Sant Joan de Deu Barcelona
Esplugues de Llobregat, Barcelona, Spain
University Hospital La Paz
Madrid, Spain