GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
Public ClinicalTrials.gov record NCT02525861. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3/4 Study to Evaluate the Safety, Immunogenicity, and Effects on the Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid Following Glassia Therapy in A1PI-Deficient Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02525861
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 34 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 8, 2016 (Actual)
- Primary completion
- Jul 29, 2020 (Actual)
- Completion
- Jul 29, 2020 (Actual)
- Last update posted
- Oct 14, 2021
2016 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Board of Regents, University of Arizona | Tucson | Arizona | 85724 | — |
| UCLA Medical Center | Los Angeles | California | 90024 | — |
| Cedars Sinai Medical Center, Division of Pulmonary and Critical Care Medicine | Los Angeles | California | 90048 | — |
| University of California Davis Health System | Sacramento | California | 95817 | — |
| University of Miami | Miami | Florida | 33136 | — |
| DBC Research Corp, Pembroke Pines | Tamarac | Florida | 33321 | — |
| Cleveland Clinic Florida - Weston | Weston | Florida | 33331 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| LaPorte County Institute for Clinical Research, Inc. | Michigan City | Indiana | 46360 | — |
| Pulmonary Critical Care Associates of Baltimore | Towson | Maryland | 21286 | — |
| Hannibal Clinic | Hannibal | Missouri | 63401 | — |
| Southeastern Research Center LLC | Winston-Salem | North Carolina | 27103 | — |
| Dayton Respiratory Research Center | Dayton | Ohio | 45415 | — |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Renovatio Clinical-Respiratory & Sleep Disorders Specialists | The Woodlands | Texas | 77005 | — |
| University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02525861, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02525861 live on ClinicalTrials.gov.