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NCT03277313 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT03277313 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 44 participants.
The verdict
NCT03277313, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of the study is to acquire additional data on efficacy, safety, tolerability, immunogenicity, pharmacokinetic (PK) and other parameters of HYQVIA in pediatric (age ≥ 2 to \<16 years) participants with primary immunodeficiency disease (PIDD).
Interventions
- BIOLOGICAL HYQVIA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2022-07-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03277313
The ClinicalTrials.gov registry entry for NCT03277313 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HYQVIA is the first listed.
NCT03277313 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03277313 about?
NCT03277313 is a clinical study titled "Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects". The purpose of the study is to acquire additional data on efficacy, safety, tolerability, immunogenicity, pharmacokinetic (PK) and other parameters of HYQVIA in pediatric (age ≥ 2 to \<16 years) participants with primary immunodeficiency disease (PIDD).
What is the current status of trial NCT03277313?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2017-09-25. Estimated completion is 2022-07-20.
What interventions are being tested in trial NCT03277313?
The interventions under investigation include: HYQVIA (BIOLOGICAL).
Who is sponsoring clinical trial NCT03277313?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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