Trial · NCT00670007
Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.
NCT00670007, Phase 4, Completed, CSL Behring; results first posted 2016-07-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency. Trials, record NCT00670007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00670007
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.
- NCT number
- NCT00670007
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 140 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Emphysema, Alpha 1-proteinase Inhibitor Deficiency
- Interventions
- Alpha1- proteinase inhibitor [human]
- First posted
- 2008-05-01
- Last updated
- 2016-08-15
- Other registries' IDs
- eudract:2007-007129-38
- Results first posted
- 2016-07-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Change of Adjusted Lung Density | Up to 2 years | As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (Total Lung Capacity; ie, full inspiration) and FRC (Functional Residual Capacity; ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in the early start and delayed start subgroups from a linear random regression model with country, inspiration state (only for 'TLC and FRC state'), time (time elapsed since Day 1 \[CE1226\_4001\]), treatment and treatment by time interaction as fixed effects and subject and subject by time interaction as random coefficients. |
| Secondary | Absolute Change in Adjusted Lung Density | From baseline to 2 years | Absolute change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average absolute change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226\_4001. |
| Secondary | Percent Change in Adjusted Lung Density | From baseline to 2 years | Percent change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average percent change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226\_4001. |
| Secondary | Change in Subject-reported Symptoms | From baseline to 2 years | Patient-reported symptoms were measured using the St George's Respiratory Questionnaire (SGRQ). SGRQ total, symptoms, activity and impact scores range from 0 to 100, with higher scores indicating more limitations, and change from baseline below zero (0) is favorable, indicating improvement. |
| Secondary | Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) | From baseline up to 2 years | |
| Secondary | Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity) | From baseline up to 2 years | |
| Secondary | Percent Change in Lung Function as Measured by Percent Predicted FEV1 | From baseline up to 2 years | |
| Secondary | Number of Subjects With Pulmonary Exacerbations | Up to 2 years | |
| Secondary | Annual Rate in Subject Years of Pulmonary Exacerbations | Up to 2 years | Annual exposure-adjusted incidence rate of pulmonary exacerbations. |
| Secondary | Time to First Pulmonary Exacerbation | Up to 2 years |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Change of Adjusted Lung Density | Up to 2 years | Intention-to-treat (ITT) population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | g/L per year | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in Adjusted Lung Density | From baseline to 2 years | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | g/L | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Adjusted Lung Density | From baseline to 2 years | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Percent change from baseline | MEAN |
| SECONDARY | Change in Subject-reported Symptoms | From baseline to 2 years | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | units on a scale (change from baseline) | MEAN |
| SECONDARY | Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) | From baseline up to 2 years | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Percent change from baseline | MEAN |
| SECONDARY | Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity) | From baseline up to 2 years | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Percent change from baseline | MEAN |
| SECONDARY | Percent Change in Lung Function as Measured by Percent Predicted FEV1 | From baseline up to 2 years | ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments. | Percent change from baseline | MEAN |
| SECONDARY | Number of Subjects With Pulmonary Exacerbations | Up to 2 years | ITT population. | participants | NUMBER |
| SECONDARY | Annual Rate in Subject Years of Pulmonary Exacerbations | Up to 2 years | ITT population. | Exacerbations/subject year | NUMBER |
| SECONDARY | Time to First Pulmonary Exacerbation | Up to 2 years | ITT population. | years | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Change of Adjusted Lung Density | Zemaira® (Early Start) | TLC + FRC combined | -1.632 | Standard Error 0.2824 | g/L per year |
| Rate of Change of Adjusted Lung Density | Zemaira® (Delayed Start) | TLC + FRC combined | -1.352 | Standard Error 0.2961 | g/L per year |
| Rate of Change of Adjusted Lung Density | Zemaira® (Early Start) | TLC | -1.627 | Standard Error 0.2743 | g/L per year |
| Rate of Change of Adjusted Lung Density | Zemaira® (Delayed Start) | TLC | -1.256 | Standard Error 0.2891 | g/L per year |
| Rate of Change of Adjusted Lung Density | Zemaira® (Early Start) | FRC | -1.658 | Standard Error 0.3186 | g/L per year |
| Rate of Change of Adjusted Lung Density | Zemaira® (Delayed Start) | FRC | -1.482 | Standard Error 0.3346 | g/L per year |
| Absolute Change in Adjusted Lung Density | Zemaira® (Early Start) | TLC + FRC combined, n = 64, 60 | -3.031 | Standard Error 0.5888 | g/L |
| Absolute Change in Adjusted Lung Density | Zemaira® (Delayed Start) | TLC + FRC combined, n = 64, 60 | -2.502 | Standard Error 0.6142 | g/L |
| Absolute Change in Adjusted Lung Density | Zemaira® (Early Start) | TLC, n = 64, 59 | -2.971 | Standard Error 0.5826 | g/L |
| Absolute Change in Adjusted Lung Density | Zemaira® (Delayed Start) | TLC, n = 64, 59 | -2.485 | Standard Error 0.6142 | g/L |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zemaira® | 140 | |
| Overall Study | COMPLETED | Zemaira® | 131 | |
| Overall Study | NOT COMPLETED | Zemaira® | 9 |
Source ClinicalTrials.gov
Adverse events68
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 | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Zemaira® | 50 | 140 | 137 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Zemaira® | 19 | 140 | 21 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Zemaira® | 17 | 140 | 40 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Zemaira® | 15 | 140 | 27 |
| other | Headache | Nervous system disorders | Zemaira® | 28 | 140 | 58 |
| other | Condition aggravated | General disorders | Zemaira® | 27 | 140 | 71 |
| other | Oedema peripheral | General disorders | Zemaira® | 12 | 140 | 13 |
| other | Pyrexia | General disorders | Zemaira® | 10 | 140 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | Zemaira® | 11 | 140 | 11 |
| other | Nausea | Gastrointestinal disorders | Zemaira® | 10 | 140 | 11 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zemaira® | ||
| Total, other adverse events | Zemaira® | 137 | 140 |
| Total, serious adverse events | Zemaira® | 51 | 140 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00670007
GET https://conductscience.org/api/trials/v1/NCT00670007/results?page=2