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COMPLETED
NCT05755035
PHASE2/PHASE3

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

Sponsor: Takeda

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

TAK-881

Participants will receive SC infusion of TAK-881.

BIOLOGICAL

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