Trial · NCT00313144

Aralast alpha1-proteinase Inhibitor Surveillance Study

NCT00313144, Phase 4, Terminated, Baxalta now part of Shire; results first posted 2011-08-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Aralast alpha1-proteinase Inhibitor Surveillance Study. Trials, record NCT00313144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00313144

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Aralast alpha1-proteinase Inhibitor Surveillance Study
NCT number: NCT00313144
Status: Terminated
Phases: Phase 4
Enrollment: 127 participants, actual
Lead sponsor: Baxalta now part of Shire
Conditions: Alpha1-antitrypsin Deficiency
Interventions: ARALAST Alpha1-Proteinase Inhibitor
First posted: 2006-04-12
Last updated: 2021-05-26
Results first posted: 2011-08-26
Limitations and caveats: Study was terminated early due to Aralast being phased out of the market.

Source ClinicalTrials.gov

Registered outcomes24

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Primary	HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Primary	HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Primary	HRQoL 'General Health (GH)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Primary	HRQoL 'Vitality (VT)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Primary	HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Primary	HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Primary	HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Primary	HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.
Primary	HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The MCS is a summary scale of the dimensions vitality, social functioning, role emotional, and mental health Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN
PRIMARY	HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN
PRIMARY	HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN
PRIMARY	HRQoL 'General Health (GH)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN
PRIMARY	HRQoL 'Vitality (VT)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN
PRIMARY	HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN
PRIMARY	HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN
PRIMARY	HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN
PRIMARY	HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN
PRIMARY	HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months	Screening to ≤ 6 Months	Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL	Scores on a scale	MEAN

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group261

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months	Baseline	31.958	Standard Deviation 11.291	Scores on a scale
HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months	Baseline to ≤6 Months	33.129	Standard Deviation 11.527	Scores on a scale
HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months	Baseline	37.631	Standard Deviation 11.819	Scores on a scale
HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months	Baseline to ≤6 Months	38.139	Standard Deviation 11.338	Scores on a scale
HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months	Baseline	46.474	Standard Deviation 10.895	Scores on a scale
HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months	Baseline to ≤6 Months	48.950	Standard Deviation 11.579	Scores on a scale
HRQoL 'General Health (GH)' From Baseline to ≤6 Months	Baseline	37.365	Standard Deviation 10.038	Scores on a scale
HRQoL 'General Health (GH)' From Baseline to ≤6 Months	Baseline to ≤6 Months	38.737	Standard Deviation 10.490	Scores on a scale
HRQoL 'Vitality (VT)' From Baseline to ≤6 Months	Baseline	42.578	Standard Deviation 11.164	Scores on a scale
HRQoL 'Vitality (VT)' From Baseline to ≤6 Months	Baseline to ≤6 Months	45.081	Standard Deviation 10.916	Scores on a scale

1 to 10 of 261Source ClinicalTrials.gov

See all 261 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Overall Study	127
Overall Study	COMPLETED	Overall Study	17
Overall Study	NOT COMPLETED	Overall Study	110

Source ClinicalTrials.gov

Adverse events35

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	Diarrhea	Gastrointestinal disorders	Overall Study	7	127	21
other	Fatigue	General disorders	Overall Study	15	127	123
other	Infusion related reaction	General disorders	Overall Study	9	127	13
other	Hypersensitivity	Immune system disorders	Overall Study	13	127	28
other	Influenza	Infections and infestations	Overall Study	7	127	27
other	Lower respiratory tract infection	Infections and infestations	Overall Study	24	127	35
other	Oral fungal infection	Infections and infestations	Overall Study	10	127	18
other	Respiratory tract infection	Infections and infestations	Overall Study	33	127	66
other	Upper respiratory tract infection	Infections and infestations	Overall Study	28	127	45
other	Headache	Nervous system disorders	Overall Study	23	127	98

1 to 10 of 35Source ClinicalTrials.gov

See all 35 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Overall Study
Total, other adverse events	Overall Study	97	127
Total, serious adverse events	Overall Study	39	127

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00313144

GET https://conductscience.org/api/trials/v1/NCT00313144/registered?page=2

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