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NCT02525861 · ClinicalTrials.gov registry record · Phase 3
GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
NCT02525861: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT02525861 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02525861, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of the study is 2-fold: (1) to evaluate the safety and potential immunogenicity of GLASSIA following intravenous (IV) administration via in-line filtration; and (2) to assess the effects of GLASSIA augmentation therapy on the levels of A1PI and various biomarkers in the epithelial lining fluid (ELF) following intravenous (IV) administration at a dosage of 60 milligrams per kilogram (mg/kg) Body weight (BW)/week active alpha1-proteinase inhibitor (A1PI) protein for 25 weeks in participants with emphysema due to congenital A1PI deficiency.
Primary Outcome
An Adverse Events (AEs) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Any AE that occurs on or after the first dose of IP infusion will be considered a TEAE. A TEAE that is considered potentially related to the presence of protein aggregates (particle load) in the GLASSIA solution is defined as any embolic or thrombotic event. Number of participants with TEAEs potentially related to the
Interventions
- BIOLOGICAL GLASSIA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-03-08 |
| Est. Completion | 2020-07-29 |
| Phase | Phase 3 |
What the finished NCT02525861 record still lists
NCT02525861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which GLASSIA is the first listed.
NCT02525861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02525861 about?
NCT02525861 is a clinical study titled "GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study". The purpose of the study is 2-fold: (1) to evaluate the safety and potential immunogenicity of GLASSIA following intravenous (IV) administration via in-line filtration; and (2) to assess the effects of GLASSIA augmentation therapy on the levels of A1PI and various biomarkers in the epithelial lining...
What is the current status of trial NCT02525861?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2016-03-08. Estimated completion is 2020-07-29.
What interventions are being tested in trial NCT02525861?
The interventions under investigation include: GLASSIA (BIOLOGICAL).
Who is sponsoring clinical trial NCT02525861?
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 NCT02525861's enrollment target sits among peer trials
34 1905th of 2000 higher than 94 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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