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NCT05269082 · ClinicalTrials.gov registry record
A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults
A clinical trial, sponsored by Takeda.
- Completed
- Registry status
- 72
- Enrollment target
NCT05269082: Completed study, sponsored by Takeda.
NCT05269082 is a clinical trial that has completed, run by Takeda. The registered enrollment target is 72 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05269082 has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- 72 participants
- Enrollment target
Study 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 hypersensitive to immunoglobulin products. 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.
Primary Outcome
Levels of in vitro hypersensitivity to TAK-880 in comparison to a reference product (Gammagard S/D) using hypersensitivity assays to address (but not limited to) immune cell activation and cytokine secretion, stratified by anti-IgA antibody levels will be evaluated during the study. Number of participants with In vitro hypersensitivity to TAK-880 in comparison to Gammagard S/D will be reported.
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2022-04-05 |
| Est. Completion | 2022-09-19 |
What the finished NCT05269082 record still lists
NCT05269082 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 72 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.
NCT05269082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05269082 about?
NCT05269082 is a clinical study titled "A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults". 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 hypersensitive to immunoglobulin products. This study is about collecting data available in the participant's...
What is the current status of trial NCT05269082?
This trial is currently completed. The enrollment target is 72 participants. The study started on 2022-04-05. Estimated completion is 2022-09-19.
What interventions are being tested in trial NCT05269082?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT05269082?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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