Phase
Condition
Primary Immunodeficiency Disorders
Hiv Infections
Treatment
HYQVIA
TAK-881
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Participant must have a documented diagnosis of a form of primary humoral immunodeficiency involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies (IUIS) Committee.
Participant is 2 years to <16 years at the time of signing the informed consent form (ICF) for the single arm treatment part of the study OR 16 years or older at the time of signing the ICF for the crossover part of the study.
Participant has received a stable dose of regular treatment with any IGIV OR HYQVIA with a treatment interval of every 21 or 28 days OR any cIGSC with a treatment interval of every 7 or 14 days over a period of at least 12 weeks prior to screening at a minimum prestudy IgG dose equivalent to 0.3 grams per kilograms per body weight per 4 weeks (g/kg BW/4 weeks) and a maximum dose equivalent to 1 g/kg BW/4 weeks. Over that period, the participant should have been on the same product of IGIV, HYQVIA, or cIGSC. A stable dose is defined as one that deviates less than +-25 percentage (%) from the mean dose for all IgG infusions within this 12-week period prior to screening. Variations in the treatment interval of up to +-5 days for participant with a 28-day treatment interval and of up to +-3 days for participant with a 7, 14, or 21-day treatment interval are acceptable up to the first IP infusion.
Participant has a serum trough level of IgG greater than (>) 5 grams per liter (g/L) at the following time points:
At screening (sample taken prior to prestudy IgG infusion after signing the ICF) and
Within 12 weeks prior to screening.
If female of childbearing potential, participant presents with a negative pregnancy test and agrees to employ highly effective form of contraception for the duration of the study.
Participant/Participant's parent(s)/legal guardian(s) is/are willing and able to comply with the requirements of the protocol, including PK blood sampling, for the duration of the study.
Informed Consent
The participant or the participant's parents/legal guardians is/are willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator.
The participant/Participant's parents/legal guardians has/have provided informed consent/assent, if applicable, (that is, in writing, documented via a signed and dated ICF and/or eConsent, if available), and any required privacy authorization prior to the initiation of any study procedures.
Exclusion Criteria
Participant has a known history of a positive result or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2. Cured participants with a history of hepatitis C infection who have a negative PCR test at screening is eligible.
Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
Persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5* the upper limit of normal (ULN) for the testing laboratory.
Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] less than and equal to (<=) 500 per cubic millimeter (/mm^3).
Known history of chronic kidney disease or estimated glomerular filtration rate (eGFR) of <60 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) at screening.
Participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator.
Participant has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IV immunoglobulin, SC immunoglobulin, and/or immune serum globulin infusions.
Participants with a known systemic hypersensitivity to any of the excipients of TAK-881/HYQVIA in accordance with the Investigator's Brochure (IB)/package insert/Summary of Product Characteristics (SmPC).
Known substance or prescription drug abuse within 12 months of screening.
Participant has immunoglobulin A (IgA) deficiency (IgA less than 0.07 g/L) associated with known anti-IgA antibodies and a history of hypersensitivity.
Participant has a known systemic hypersensitivity to hyaluronidase or rHuPH20.
Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening.
Participant has a bleeding disorder, or a platelet count less than 20,000 per microliter (mcL), or in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of immune globulin subcutaneous (IGSC) therapy.
Treatment with immunosuppressants including chemotherapeutic agents, immunomodulators, and long-term systemic corticosteroid (defined as a daily dose of >1 mg of prednisone equivalent/kg/day for >30 days) within 12 weeks prior to screening. Short or intermittent courses (<=10 days) of corticosteroids are allowed.
Live-attenuated viral vaccination within 12 weeks prior to screening.
History or current diagnosis of thrombotic episodes; venous thrombus that occurred in association with a medical device >2 years prior to screening are allowed.
Participant has severe dermatitis that would preclude adequate sites for safe product administration in the opinion of the investigator.
Participant has a medical condition, laboratory finding, or physical examination finding that precludes participation, or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the study or place the participant at undue medical risk.
Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening.
Participant is scheduled to participate in another clinical study involving an IP (except for participants scheduled to enroll in a long-term follow-up study with TAK-881) or investigational device during the course of this study.
Participant is a family member or employee of the investigator or the investigator's site staff.
If female, participant is pregnant or lactating at the time of screening.
Study Design
Study Description
Connect with a study center
Fakultni nemocnice u sv. Anny v Brne - ICRC
Brno, 656 91
CzechiaSite Not Available
University Hospital Brno (Fakultni Nemocnice Brno) - Children's Hospital (Detska nemocnice)
Brno, 62500
CzechiaSite Not Available
Fakultni Nemocnice Ostrava (FNO)
Ostrava-Poruba, 708 52
CzechiaSite Not Available
Fakultni Nemocnice v Motole
Prague, 14300
CzechiaSite Not Available
Aarhus Universitetshospital
Aarhus, 8200
DenmarkSite Not Available
Odense University Hospital
Odense, 5000
DenmarkSite Not Available
University Hospital Carl Gustav Carus
Dresden, 01307
GermanySite Not Available
Universitatsklinikum Freiburg -Centrum für Chronische Immundefizienz - CCI
Freiburg, 79106
GermanySite Not Available
Universitaetsklinikum Tuebingen (UKT)
Tuebingen, 72076
GermanySite Not Available
Maastricht Universitair Medisch Centrum (MUMC), Academic Hospital Maastricht
Maastricht, 6229 HX
NetherlandsSite Not Available
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, 3584 CX
NetherlandsSite Not Available
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, Kujawsko-pomorskie 85-168
PolandSite Not Available
Centrum Onkologii Ziemii Lubelskiej im. sw. Jana z Dukli
Lublin, Lubelskie 20-090
PolandSite Not Available
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Mazowieckie 00-999
PolandSite Not Available
Wojskowy Instytut Medyczny,Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
Warszawa, Mazowieckie 04-141
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne, KLINIKA PEDIATRII, HEMATOLOGII I ONKOLOGII
Gdansk, Pomorskie 80-952
PolandSite Not Available
Osrodek Pediatryczny im. DR J. Korczaka, Wojewodzkie Wielospecjalistyczne Centrum i Traumatologii im. M. Kopernika w Lodzi
Lodz, 90329
PolandSite Not Available
NUDCH (National Institute of Children's Diseases)
Bratislava, 833 40
SlovakiaSite Not Available
OKIA, s.r.o
Kosice, 040 01
SlovakiaSite Not Available
Klinika Deti a Dorastu - Odborne Ambulancie UNM a JLF UK Martin
Martin, 036 01
SlovakiaSite Not Available
Hospital Sant Joan de Deu Barcelona
Esplugues De Llobregat, Barcelona 08950
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
University Hospital La Paz
Madrid, 28046
SpainSite Not Available
University of California Irvine Medical Center
Irvine, California 92697
United StatesActive - Recruiting
Allergy and Asthma Clinical Research
Walnut Creek, California 94598
United StatesSite Not Available
National Jewish Medical And Research Center
Denver, Colorado 80206
United StatesSite Not Available
University of South Florida
Saint Petersburg, Florida 33701
United StatesSite Not Available
Central Georgia Infectious Disease Consultants
Macon, Georgia 31201
United StatesActive - Recruiting
Rush University Medical Center - University Cardiovascular Surgeons
Chicago, Illinois 60612-3852
United StatesSite Not Available
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois 61761
United StatesActive - Recruiting
Louisiana State University Health Science Center-New Orleans
New Orleans, Louisiana 70118
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10461
United StatesActive - Recruiting
Northwell Health
Great Neck, New York 11021
United StatesSite Not Available
Duke Asthma, Allergy and Airway Center
Durham, North Carolina 27705
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195-0001
United StatesSite Not Available
Nationwide Childrens Hospital
Columbus, Ohio 43205
United StatesSite Not Available
Optimed Research, LTD
Columbus, Ohio 43235
United StatesActive - Recruiting
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma 74136
United StatesActive - Recruiting
Allergy Partners of North Texas
Dallas, Texas 75230
United StatesActive - Recruiting
Tanner Clinic
Murray, Utah 84107
United StatesActive - Recruiting
Children's Hospital Of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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