A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults
NCT ID: NCT05269082
Last Updated: 2022-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2022-04-05
2022-09-19
Brief Summary
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This study is about collecting data available in the participant's medical record. No study medicines will be provided to participants in this study. Each participant will fill out a study questionnaire during a routine doctor visit. Blood will be taken from participants who have a higher risk of developing hypersensitivity reactions to immunoglobulin products.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Cohort 1
Pediatric and adult participants who are on Gammagard S/D prescribed for any approved indication will be enrolled in this cohort and evaluated during the observation period (approximately 6 months).
No intervention
This is a non-interventional study.
Cohort 2
Pediatric and adult participants who were previously treated with Gammagard S/D prescribed for any approved indication and are on another human immunoglobulin treatment will be enrolled in this cohort and evaluated during the observation period (approximately 6 months).
No intervention
This is a non-interventional study.
Cohort 3
Pediatric and adult primary immunodeficiency (PID) participants with immunoglobin A (IgA) deficiency who have a serum IgA level of less than (\<) 7 milligrams per deciliter (mg/dL) (0.07 grams/liter \[g/L\]) or below the detectable limit and have received other therapies (prophylactic antibiotics or immunoglobulin treatment other than Gammagard S/D) will be enrolled in this cohort and evaluated during the observation period (approximately 6 months).
No intervention
This is a non-interventional study.
Interventions
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No intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion Criteria
* 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.
2 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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PPD
Wilmington, North Carolina, United States
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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TAK-880-5001
Identifier Type: -
Identifier Source: org_study_id
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