Trial · NCT00396006
Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)
NCT00396006, Phase 4, Completed, Baxalta now part of Shire; results first posted 2011-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor). Trials, record NCT00396006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00396006
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)
- NCT number
- NCT00396006
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 21 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Alpha 1-Antitrypsin Deficiency
- Interventions
- Alpha1-Proteinase Inhibitor
- First posted
- 2006-11-06
- Last updated
- 2021-05-13
- Results first posted
- 2011-01-04
- Limitations and caveats
Isoelectric focusing (IEF) analyses that were intended to compare the profile of plasma α1-PI \& ELF α1-PI were not carried out due to fact that ELF samples were either missing, insufficient or too dilute for such assays.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Bronchoalveolar Lavage (BAL) Epithelial Lining Fluid (ELF) Alpha1-Proteinase Inhibitor (α1-PI) Level | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Median change BAL ELF antigenic α1-PI level the from baseline to post-treatment |
| Primary | The Number of Adverse Events (AEs) Related to the Infusion of ARALAST Fr. IV 1 Administered at a Rate of 0.2 mL/kg/Min | During 8 consecutive weeks of treatment | |
| Primary | Number of Changes in the Rate of Infusion | During 8 consecutive weeks of treatment | Number of decreases in the rate or discontinuations of infusion at 0.2 mL/kg/min |
| Secondary | Ratio of Post- to Pre-treatment BAL ELF Antineutrophil Elastase Capacity (ANEC) Levels | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Median ratio of post- to pre-treatment BAL ELF ANEC levels |
| Secondary | Change in in the Ratio of BAL ELF α1-PI to Human Neutrophil Elastase (HNE) Complex Concentration | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Median change in the ratio of BAL ELF α1-PI to HNE complex concentration from baseline to post-treatment |
| Secondary | Change in the α1-PI Plasma Level | Blood samples were collected at baseline and after 8 consecutive weeks of treatment | Mean change in the plasma level of α1-PI from baseline to post-treatment |
| Secondary | Change in the Plasma Antineutrophil Elastase Capacity (ANEC) Level | Blood samples were collected at baseline and after 8 consecutive weeks of treatment | Mean change in the plasma ANEC level from baseline to post-treatment |
| Secondary | Clinically Significant Changes in Vital Signs From Pre- to Post-Infusion | During 8 consecutive weeks of infusion | Clinically significant changes in vital signs from pre- to post-infusion are: • Heart rate: 25% increase above pre-infusion value • Blood pressure: ≥ 30 mm Hg change from pre-infusion blood pressure (systolic or diastolic) • Temperature: an increase in body temperature to \>38°C (\>100.4°F). If the pre-infusion body temperature was already \>38°C (\>100.4°F), then any further increase in body temperature by 1.1°C (1.98°F) or more was considered clinically significant. • Respiratory rate: 25% increase above pre-infusion value |
| Other | Change in the BAL ELF Free Neutrophil Elastase Level | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Median change in the BAL ELF Free Neutrophil Elastase Level from baseline to post-treatment |
| Other | Ratio of Post- to Pre-treatment BAL ELF Total Neutrophil Elastase Level | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Median ratio of post- to pre-treatment BAL ELF Total Neutrophil Elastase Level |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Bronchoalveolar Lavage (BAL) Epithelial Lining Fluid (ELF) Alpha1-Proteinase Inhibitor (α1-PI) Level | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Per protocol | μM | MEDIAN |
| PRIMARY | The Number of Adverse Events (AEs) Related to the Infusion of ARALAST Fr. IV 1 Administered at a Rate of 0.2 mL/kg/Min | During 8 consecutive weeks of treatment | Intent to treat | adverse events | NUMBER |
| SECONDARY | Ratio of Post- to Pre-treatment BAL ELF Antineutrophil Elastase Capacity (ANEC) Levels | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Per protocol | μM | MEDIAN |
| SECONDARY | Change in in the Ratio of BAL ELF α1-PI to Human Neutrophil Elastase (HNE) Complex Concentration | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | No per protocol subject had both pre- and post-treatment analytes available, therefore no analysis could be performed on this outcome measure | ||
| SECONDARY | Change in the α1-PI Plasma Level | Blood samples were collected at baseline and after 8 consecutive weeks of treatment | Per protocol | μM | MEAN |
| SECONDARY | Change in the Plasma Antineutrophil Elastase Capacity (ANEC) Level | Blood samples were collected at baseline and after 8 consecutive weeks of treatment | Per protocol | μM | MEAN |
| OTHER_PRE_SPECIFIED | Change in the BAL ELF Free Neutrophil Elastase Level | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Per protocol population with both pre- and post-treatment analytes available from BAL procedures | nM | MEDIAN |
| OTHER_PRE_SPECIFIED | Ratio of Post- to Pre-treatment BAL ELF Total Neutrophil Elastase Level | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Per protocol | nM | MEDIAN |
| OTHER_PRE_SPECIFIED | Ratio of Post- to Pre-treatment BAL ELF Interleukin 8 (IL-8) Level | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Per protocol | pg/mL | MEDIAN |
| OTHER_PRE_SPECIFIED | Change in the BAL ELF Tumor Necrosis Factor-alpha (TNF-α) From Baseline to Post-treatment | BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks) | Per protocol population with both pre- and post-treatment analytes available from BAL procedures |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Bronchoalveolar Lavage (BAL) Epithelial Lining Fluid (ELF) Alpha1-Proteinase Inhibitor (α1-PI) Level | Per Protocol | 0.28 | Full Range -0.24 to 4.90 | μM | |
| The Number of Adverse Events (AEs) Related to the Infusion of ARALAST Fr. IV 1 Administered at a Rate of 0.2 mL/kg/Min | Intent to Treat | 0 | adverse events | ||
| Ratio of Post- to Pre-treatment BAL ELF Antineutrophil Elastase Capacity (ANEC) Levels | Per Protocol | 1.22 | Full Range 0.63 to 1.81 | μM | |
| Change in the α1-PI Plasma Level | Per Protocol | 10.34 | Standard Deviation 2.50 | μM | |
| Change in the Plasma Antineutrophil Elastase Capacity (ANEC) Level | Per Protocol | 9.46 | Standard Deviation 2.31 | μM | |
| Change in the BAL ELF Free Neutrophil Elastase Level | Per Protocol | 41.17 | Full Range 3.91 to 41.61 | nM | |
| Ratio of Post- to Pre-treatment BAL ELF Total Neutrophil Elastase Level | Per Protocol | 1.24 | Full Range 0.47 to 30.97 | nM | |
| Ratio of Post- to Pre-treatment BAL ELF Interleukin 8 (IL-8) Level | Per Protocol | 1.46 | Full Range 0.48 to 10.38 | pg/mL | |
| Number of Changes in the Rate of Infusion | Intent to Treat | 0 | infusions | ||
| Clinically Significant Changes in Vital Signs From Pre- to Post-Infusion | Intent to Treat | 2 | # Clinically significant events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Treated With ARALAST Fraction IV-1 (Fr. IV-1) | 13 | |
| Overall Study | COMPLETED | Participants Treated With ARALAST Fraction IV-1 (Fr. IV-1) | 13 | |
| Overall Study | NOT COMPLETED | Participants Treated With ARALAST Fraction IV-1 (Fr. IV-1) | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Inflammation | General disorders | Intent to Treat | 1 | 13 | 1 |
| other | Sluggishness | General disorders | Intent to Treat | 2 | 13 | 2 |
| other | Vessel puncture site haematoma | General disorders | Intent to Treat | 1 | 13 | 1 |
| other | Bronchitis | Infections and infestations | Intent to Treat | 1 | 13 | 1 |
| other | Sinusitis | Infections and infestations | Intent to Treat | 1 | 13 | 1 |
| other | Contusion | Injury, poisoning and procedural complications | Intent to Treat | 1 | 13 | 1 |
| other | Post procedural complication | Injury, poisoning and procedural complications | Intent to Treat | 2 | 13 | 3 |
| other | Blood pressure systolic abnormal | Investigations | Intent to Treat | 1 | 13 | 1 |
| other | Respiratory rate increased | Investigations | Intent to Treat | 1 | 13 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Intent to Treat | 1 | 13 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intent to Treat | ||
| Total, other adverse events | Intent to Treat | 7 | 13 |
| Total, serious adverse events | Intent to Treat | 1 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36001294 | DERIVED |
Source PubMed
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/NCT00396006
GET https://conductscience.org/api/trials/v1/NCT00396006/registered