Trial · NCT02525861
GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
NCT02525861, Phase 3, Completed, Baxalta now part of Shire; results first posted 2021-10-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study. Trials, record NCT02525861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02525861
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
- NCT number
- NCT02525861
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 34 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Alpha1-antitrypsin Deficiency
- Interventions
- GLASSIA
- First posted
- 2015-08-18
- Last updated
- 2021-10-14
- Results first posted
- 2021-10-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution | From start of study treatment up to Week 26 | 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 presence of protein aggregates (particle load) in the GLASSIA solution were reported. |
| Primary | Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 24 Hours Following the End of IP Infusion | From start of study treatment up to 24 hours post infusion | An Treatment-emergent AR and suspected AR was any TEAE which met any of the following criteria: a; A TEAE that began during infusion or within 24 hours (or 1 day where time of onset is not available) following the end of IP infusion, or b; A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or c; A TEAE for which causality assessment was missing or indeterminate. Number of participants with both treatment-emergent ARs plus suspected ARs were collectively reported. |
| Primary | Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 72 Hours Following the End of IP Infusion | From start of study treatment up to 72 hours post infusion | An Treatment-emergent AR and suspected AR was any TEAE which met any of the following criteria: a; A TEAE that began during infusion or within 72 hours (or 3 days where time of onset is not available) following the end of IP infusion, or b; A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or c; A TEAE for which causality assessment was missing or indeterminate. Number of participants with both treatment-emergent ARs plus suspected ARs were collectively reported. |
| Primary | Number of Infusions Discontinued, Slowed, or Interrupted Due to TEAEs | From start of study treatment up to Week 26 | An AE was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Infusions may be interrupted or discontinued in an individual participant in the event of intolerable moderate to severe infusion-related AEs and/or at the discretion of the investigator. Number of infusions that are discontinued, slowed, or interrupted due to TEAEs were reported. |
| Primary | Number of Participants Who Developed Binding and/or Neutralizing Anti- Alpha1-Proteinase Inhibitor(A1PI) Antibodies | From start of study treatment up to Week 26 | Development of Binding/Neutralizing Anti-A1PI Antibodies=Negative or missing at Baseline and confirmed positive at any post-infusion time point. Participants that had a positive result at Baseline and missing at all post-infusion time points were included as "No Development". Neutralizing anti-A1PI antibodies were only assessed in case of positive binding anti-A1PI antibodies. Anti-A1PI antibodies was detected using validated binding and neutralizing anti-A1PI antibody assays at a qualified immunoassay laboratory. Number of participants who developed binding and/or neutralizing anti-A1PI antibodies were reported. |
| Primary | Change From Baseline in Antigenic Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid (ELF) | Baseline up to Week 14 | Change from baseline in antigenic A1PI levels in ELF up to Week 14 was reported. Bronchoalveolar Lavage (BAL) procedures were performed at baseline and on-treatment BAL visit during GLASSIA augmentation therapy. Data for this outcome measure was analyzed and planned to be reported based on overall arm (Arms/Groups were combined as pre-specified in the study protocol). |
| Primary | Change From Baseline in Functional Alpha1-Proteinase Inhibitor(A1PI) Levels in Epithelial Lining Fluid (ELF) | Baseline up to Week 14 | Change from baseline in functional A1PI (also known as Anti-Neutrophil Elastase Capacity \[ANEC\]) levels in ELF up to Week 14 was reported. BAL procedures were performed at baseline and on-treatment BAL visit during GLASSIA augmentation therapy. Data for this outcome measure was analyzed and planned to be reported based on overall arm (Arms/Groups were combined as pre-specified in the study protocol). |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study treatment up to Week 26 | An 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. |
| Secondary | Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26 | Baseline, Week 13, 25 and 26 | Clinical laboratory values included Hematology (hemoglobin, leukocytes, neutrophils, reticulocytes/erythrocytes \[Ret/Ery\], platelets); Chemistry (sodium, potassium, albumin, alanine aminotransferase \[AA\], aspartate aminotransferase \[ASA\], alkaline phosphatase \[AP\], lactate dehydrogenase \[LD\], gamma glutamyl transferase \[GGT\], bilirubin, direct bilirubin \[DB\], creatinine, creatine kinase \[CK\], glucose); Urinalysis (erythrocytes urine \[EU\], protein urine \[PU\], specific gravity \[SG\], pH) and Immunology (Complement C3, Complement C4). Assessment if a value was normal, clinically non-significant abnormal, or clinically significant abnormal was done by the investigator. Number of participants who experienced a shift from normal or clinically non-significant (NCS) abnormal laboratory values at baseline \[BL\] to clinically significant (CS) abnormal laboratory values at Week 13, 25 and 26 were reported. |
| Secondary | Number of Participants With Treatment-Emergent Seroconversion or Positive Nucleic Acid Test (NAT) for Parvovirus B19 (B19V) | From start of study treatment up to Week 26 | Viral testing for B19V consisted of viral serology or NAT for B19V (Parvovirus B19 IgG Antibody, Parvovirus B19 IgM Antibody, Parvovirus B19 DNA Quant real-time polymerase chain reaction \[RT-PCR\]). Number of participants with treatment-emergent seroconversion or positive NAT for B19V were reported. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution | From start of study treatment up to Week 26 | Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 24 Hours Following the End of IP Infusion | From start of study treatment up to 24 hours post infusion | Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 72 Hours Following the End of IP Infusion | From start of study treatment up to 72 hours post infusion | Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Infusions Discontinued, Slowed, or Interrupted Due to TEAEs | From start of study treatment up to Week 26 | Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. | Number of Infusions | NUMBER |
| PRIMARY | Number of Participants Who Developed Binding and/or Neutralizing Anti- Alpha1-Proteinase Inhibitor(A1PI) Antibodies | From start of study treatment up to Week 26 | Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. Here, number analyzed signifies participants who were evaluable for this outcome measure at specific category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Antigenic Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid (ELF) | Baseline up to Week 14 | BAL analysis set included a subset of the full analysis set (FAS). FAS included all enrolled participants who received at least 1 IP infusion and have at least 1 available antigenic or functional A1PI measurement (either from plasma or from ELF) during the treatment period. | Micromolar (mcM) | MEDIAN |
| PRIMARY | Change From Baseline in Functional Alpha1-Proteinase Inhibitor(A1PI) Levels in Epithelial Lining Fluid (ELF) | Baseline up to Week 14 | BAL analysis set included a subset of the FAS. FAS included all enrolled participants who received at least 1 IP infusion and have at least 1 available antigenic or functional A1PI measurement (either from plasma or from ELF) during the treatment period. | mcM | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study treatment up to Week 26 | Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Shift From Normal or Clinically Non-significant Abnormal Laboratory Values at Baseline to Clinically Significant Abnormal Laboratory Values at Week 13, 25, and 26 | Baseline, Week 13, 25 and 26 | Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for at specific time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Seroconversion or Positive Nucleic Acid Test (NAT) for Parvovirus B19 (B19V) | From start of study treatment up to Week 26 | Safety analysis set consisted of all enrolled participants who received any amount of IP, regardless of protocol deviations or non-adherence to study procedures. Here, number analyzed signifies those participants who were evaluable for this outcome measure at specific category. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group310
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution | Cohort I: GLASSIA (High-end) | 0 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution | Cohort II: GLASSIA (Low-end) | 0 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 24 Hours Following the End of IP Infusion | Cohort I: GLASSIA (High-end) | 7 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 24 Hours Following the End of IP Infusion | Cohort II: GLASSIA (Low-end) | 3 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 72 Hours Following the End of IP Infusion | Cohort I: GLASSIA (High-end) | 10 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 72 Hours Following the End of IP Infusion | Cohort II: GLASSIA (Low-end) | 7 | Participants | ||
| Number of Infusions Discontinued, Slowed, or Interrupted Due to TEAEs | Cohort I: GLASSIA (High-end) | Number of Infusions Discontinued due to TEAEs | 0 | Number of Infusions | |
| Number of Infusions Discontinued, Slowed, or Interrupted Due to TEAEs | Cohort II: GLASSIA (Low-end) | Number of Infusions Discontinued due to TEAEs | 0 | Number of Infusions | |
| Number of Infusions Discontinued, Slowed, or Interrupted Due to TEAEs | Cohort I: GLASSIA (High-end) | Number of Infusions Slowed due to TEAEs | 1 | Number of Infusions | |
| Number of Infusions Discontinued, Slowed, or Interrupted Due to TEAEs | Cohort II: GLASSIA (Low-end) | Number of Infusions Slowed due to TEAEs | 0 | Number of Infusions |
1 to 10 of 310Source ClinicalTrials.gov
See all 310 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort I: GLASSIA (High-end) | 18 | |
| Overall Study | STARTED | Cohort II: GLASSIA (Low-end) | 16 | |
| Overall Study | COMPLETED | Cohort I: GLASSIA (High-end) | 17 | |
| Overall Study | COMPLETED | Cohort II: GLASSIA (Low-end) | 14 | |
| Overall Study | NOT COMPLETED | Cohort I: GLASSIA (High-end) | 1 | |
| Overall Study | NOT COMPLETED | Cohort II: GLASSIA (Low-end) | 2 |
Source ClinicalTrials.gov
Adverse events110
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eye irritation | Eye disorders | GLASSIA (High-end) | 0 | 18 | 0 |
| other | Eye irritation | Eye disorders | GLASSIA (Low-end) | 1 | 16 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | GLASSIA (High-end) | 3 | 18 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | GLASSIA (Low-end) | 0 | 16 | 0 |
| other | Dry mouth | Gastrointestinal disorders | GLASSIA (High-end) | 0 | 18 | 0 |
| other | Dry mouth | Gastrointestinal disorders | GLASSIA (Low-end) | 1 | 16 | 1 |
| other | Lip dry | Gastrointestinal disorders | GLASSIA (High-end) | 0 | 18 | 0 |
| other | Lip dry | Gastrointestinal disorders | GLASSIA (Low-end) | 1 | 16 | 1 |
| other | Nausea | Gastrointestinal disorders | GLASSIA (High-end) | 2 | 18 | 2 |
| other | Nausea | Gastrointestinal disorders | GLASSIA (Low-end) | 0 | 16 | 0 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GLASSIA (High-end) | 0 | 18 |
| Total, all-cause mortality | GLASSIA (Low-end) | 0 | 16 |
| Total, other adverse events | GLASSIA (High-end) | 13 | 18 |
| Total, other adverse events | GLASSIA (Low-end) | 9 | 16 |
| Total, serious adverse events | GLASSIA (High-end) | 1 | 18 |
| Total, serious adverse events | GLASSIA (Low-end) | 1 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Cohort I: GLASSIA (High-end) vs Cohort II: GLASSIA (Low-end): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution | Trial comparisons |
| Cohort I: GLASSIA (High-end) vs Cohort II: GLASSIA (Low-end): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
Cohort I: GLASSIA (High-end) vs Cohort II: GLASSIA (Low-end): Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 24 Hours Following the End of IP Infusion | Trial comparisons |
| GLASSIA (High-end) vs GLASSIA (Low-end): deaths from any cause | Trial comparisons |
Cohort I: GLASSIA (High-end) vs Cohort II: GLASSIA (Low-end): Number of Participants With Treatment-Emergent Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Within 72 Hours Following the End of IP Infusion | Trial comparisons |
| GLASSIA (High-end) vs GLASSIA (Low-end): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02525861
GET https://conductscience.org/api/trials/v1/NCT02525861/results?page=2