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Completed
NCT05755035
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
Conditions: Primary Immunodeficiency Diseases (PID)
Sex: All
Ages: 2 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 65
Sponsor: Takeda
Location: University of California Irvine Medical Center Irvine California
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 \[\
Eligibility Criteria
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 \) 5 grams per liter (g/L) at the following time points:
1. At screening (sample taken prior to prestudy IgG infusion after signing the ICF) and
2. 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, or in the case of minors, legally designated representative(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, in the case of minors, legally designated representative(s) is/are willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator.
* The participant or, in the case of minors, legally designated representative(s) 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):
1. Persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2.5\* the upper limit of normal (ULN) for the testing laboratory.
2. Persistent severe neutropenia (defined as an absolute neutrophil count \[ANC\] less than and equal to (\
Source: ClinicalTrials.gov (NCT05755035). StuddyBuddy aggregates publicly available trial information.