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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 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 34 participants.
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.
Interventions
- BIOLOGICAL GLASSIA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-03-08 |
| Est. Completion | 2020-07-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02525861
The ClinicalTrials.gov registry entry for NCT02525861 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 34 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 GLASSIA is the first listed.
NCT02525861 reports 0 study locations.
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.
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