Trial · NCT00263887

Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)

NCT00263887, Phase 2, Completed, Grifols Therapeutics LLC; results first posted 2014-08-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE). Trials, record NCT00263887. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00263887

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Trial

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

Title: Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)
NCT number: NCT00263887
Status: Completed
Phases: Phase 2
Enrollment: 77 participants, actual
Lead sponsor: Grifols Therapeutics LLC
Conditions: Alpha 1-Antitrypsin Deficiency
Interventions: Alpha1-Proteinase Inhibitor (Human), Albumin (Human) 20%, United States Pharmacopeia (USP)
First posted: 2005-12-09
Last updated: 2014-08-21
Results first posted: 2014-08-21

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame
Primary	The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung	24 or 30 months
Secondary	Change in Lung Density at Each Visit as Measured by Computed Tomography	24 or 30 months
Secondary	The Frequency of Exacerbations as Determined by Patient Diary.	24 or 30 months
Secondary	The Deterioration of the Lung Function Will be Assessed by Measurement of the Change in Forced Expiratory Volume at One Second (FEV1) and Transfer Factor of Carbon Monoxide (KCO)	24 or 30 months
Secondary	Duration and Severity of the Exacerbations	24 or 30 months
Secondary	Mortality	24 or 30 months
Secondary	Quality of Life With a Disease Specific Instrument, the St. George's Respiratory Questionnaire	24 or 30 months

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung	24 or 30 months	The modified Intent-To-Treat Population was defined as all subjects in the Intent-To-Treat (ITT) Population (all randomized subjects) who had a valid baseline CT scan and at least one valid post-baseline CT scan measurement.	g/L	MEAN
SECONDARY	Change in Lung Density at Each Visit as Measured by Computed Tomography	24 or 30 months		g/L	MEAN
SECONDARY	The Frequency of Exacerbations as Determined by Patient Diary.	24 or 30 months
SECONDARY	The Deterioration of the Lung Function Will be Assessed by Measurement of the Change in Forced Expiratory Volume at One Second (FEV1) and Transfer Factor of Carbon Monoxide (KCO)	24 or 30 months
SECONDARY	Duration and Severity of the Exacerbations	24 or 30 months
SECONDARY	Mortality	24 or 30 months
SECONDARY	Quality of Life With a Disease Specific Instrument, the St. George's Respiratory Questionnaire	24 or 30 months

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Spread	Units
The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung	Prolastin (60 mg/kg Body Weight)	Baseline	47.980	Standard Deviation 19.072	g/L
The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung	Placebo	Baseline	45.477	Standard Deviation 16.949	g/L
The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung	Prolastin (60 mg/kg Body Weight)	Endpoint	45.085	Standard Deviation 19.433	g/L
The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung	Placebo	Endpoint	41.354	Standard Deviation 16.260	g/L
The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung	Prolastin (60 mg/kg Body Weight)	Change from Baseline	-2.895	Standard Deviation 4.739	g/L
The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung	Placebo	Change from Baseline	-4.124	Standard Deviation 4.147	g/L

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Prolastin (60 mg/kg Body Weight)	38
Overall Study	STARTED	Placebo	39
Overall Study	COMPLETED	Prolastin (60 mg/kg Body Weight)	35
Overall Study	COMPLETED	Placebo	32
Overall Study	NOT COMPLETED	Prolastin (60 mg/kg Body Weight)	3
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events188

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
other	Angina pectoris	Cardiac disorders	Prolastin (60 mg/kg Body Weight)	2	38
other	Angina pectoris	Cardiac disorders	Placebo	1	39
other	Conjunctivitis	Eye disorders	Prolastin (60 mg/kg Body Weight)	0	38
other	Conjunctivitis	Eye disorders	Placebo	2	39
other	Abdominal pain upper	Gastrointestinal disorders	Prolastin (60 mg/kg Body Weight)	3	38
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	4	39
other	Diarrhoea	Gastrointestinal disorders	Prolastin (60 mg/kg Body Weight)	3	38
other	Diarrhoea	Gastrointestinal disorders	Placebo	5	39
other	Mouth ulceration	Gastrointestinal disorders	Prolastin (60 mg/kg Body Weight)	2	38
other	Mouth ulceration	Gastrointestinal disorders	Placebo	0	39

1 to 10 of 188Source ClinicalTrials.gov

See all 188 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prolastin (60 mg/kg Body Weight)
Total, all-cause mortality	Placebo
Total, other adverse events	Prolastin (60 mg/kg Body Weight)	37	38
Total, other adverse events	Placebo	38	39
Total, serious adverse events	Prolastin (60 mg/kg Body Weight)	9	38
Total, serious adverse events	Placebo	15	39

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19196813	RESULT	PubMed
19251783	RESULT	PubMed
19483042	RESULT	PubMed
19678952	DERIVED	PubMed
20920370	DERIVED	PubMed
21617168	DERIVED	PubMed
23226015	DERIVED	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Prolastin (60 mg/kg Body Weight) vs Placebo: serious adverse events

Source 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.

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/NCT00263887

GET https://conductscience.org/api/trials/v1/NCT00263887/events?page=2

API reference For AI assistants