Status:
COMPLETED
A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults
Lead Sponsor:
Takeda
Conditions:
Drug Hypersensitivity
Eligibility:
All Genders
2+ years
Brief Summary
The aim of this study is to find out whether TAK-880 creates hypersensitivity reactions compared to Gammagard S/D by testing blood taken from participants who have a higher risk of becoming hypersensi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- At least 2 years of age except PID participants with selective IgA deficiency (the lower age limit in this group of participants is 4 years of age).
- Participant has previously received at least one infusion of Gammagard S/D prescribed for any approved indication (PID, B-cell Chronic Lymphocytic Leukemia, Idiopathic Thrombocytopenic Purpura, Kawasaki Syndrome) OR PID participant with IgA deficiency (serum IgA level of \< 7 mg/dL (0.07 g/L) or below the detectable limit in participants older than 4 years) and has received other therapies (prophylactic antibiotics or immunoglobulin treatment other than Gammagard S/D).
- Participant/legally authorized representative is willing to sign an informed consent form or assent form as applicable and is able to comply with the requirements of the protocol.
- Exclusion criteria:
- There are no applicable exclusion criteria for this study.
Exclusion
Key Trial Info
Start Date :
April 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 19 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05269082
Start Date
April 5 2022
End Date
September 19 2022
Last Update
September 23 2022
Active Locations (1)
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1
PPD
Wilmington, North Carolina, United States, 28401