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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: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT03277313 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The rate of ASBI was defined as the mean number of ASBI per participant-year based on the United States (U.S.) Food and drugs Administration (FDA) guidance for industry to support marketing of human immune globulin intravenous (IGIV) as replacement therapy for primary humoral immunodeficiency and the European Medicines Agency (EMA) guideline on the clinical investigation of human normal immunoglobulin for SC and /or intramuscular administration. ASBI included bacteremia/sepsis, bacterial meningi
Interventions
- BIOLOGICAL HYQVIA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-09-25 |
| Est. Completion | 2022-07-20 |
| Phase | Phase 3 |
What the finished NCT03277313 record still lists
NCT03277313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which HYQVIA is the first listed.
NCT03277313 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03277313's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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