Trial · NCT00242385

Pharmacokinetic Study of ARALAST (Human Alpha1- PI)

NCT00242385, Phase 1, Completed, Baxalta now part of Shire; results first posted 2011-07-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pharmacokinetic Study of ARALAST (Human Alpha1- PI). Trials, record NCT00242385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00242385

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Trial

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

Title: Pharmacokinetic Study of ARALAST (Human Alpha1- PI)
NCT number: NCT00242385
Status: Completed
Phases: Phase 1
Enrollment: 25 participants, actual
Lead sponsor: Baxalta now part of Shire
Conditions: Alpha 1-Antitrypsin Deficiency
Interventions: Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor, Dose of 60 mg/kg alpha1-proteinase inhibitor
First posted: 2005-10-20
Last updated: 2021-05-13
Results first posted: 2011-07-20

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Area Under the Curve/Dose	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Area under the plasma alpha1-proteinase inhibitor (α1-PI) concentration versus time curve (AUC) calculated by linear trapezoidal method per dose.
Secondary	Total Area Under the Curve Per Dose	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Total area under the α1-PI concentration vs. time curve from pharmacokinetic day 0 to time infinity (AUC 0-infinity) per dose
Secondary	Systemic Clearance (CL)	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Computed as dose divided by AUC 0-infinity (AUC 0-infinity was calculated as the sum of AUC from time 0 to the time of last quantifiable concentration plus a tail area correction)
Secondary	Mean Residence Time (MRT)	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Computed as total area under the moment curve (AUMC) divided by total AUC
Secondary	Apparent Volume of Distribution at Steady State	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Computed as weight-adjusted CL \* MRT
Secondary	Terminal Half-life	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Computed from the terminal or disposition rate constant obtained from log\_e -linear fitting using the least squares deviation to the last five quantifiable concentrations above pre-infusion level.
Secondary	Maximum Plasma Concentration (Cmax)	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Maximum α1-PI concentration following infusion
Secondary	Time to Maximum α1-PI Concentration Post-infusion (Tmax)	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Time to reach C-max. Tmax is the number of days from infusion to maximum concentration. Samples drawn at the end of infusion are considered to be time zero.
Secondary	Incremental Recovery	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Computed from Cmax (mg/ml) divided by dose per kg body weight (mg/kg).
Secondary	Adverse Events (AEs)	Throughout study period (7 months)	Investigators assessed severity of AEs (occurring during or after infusions) based on: MILD: Transient discomfort, does not interfere in a significant manner with participant's normal functioning level; Resolves spontaneously or may require minimal therapeutic intervention MODERATE: AE produces limited impairment of function, can require therapeutic intervention; AE produces no sequelae; SEVERE: AE results in marked impairment of function, can lead to temporary inability to resume usual life pattern; AE produces sequelae, which require prolonged therapeutic intervention

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	Area Under the Curve/Dose	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	All study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis	days*kg/mL	MEDIAN
SECONDARY	Total Area Under the Curve Per Dose	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis	days*kg/mL	MEDIAN
SECONDARY	Systemic Clearance (CL)	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis	mL/day	MEDIAN
SECONDARY	Mean Residence Time (MRT)	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis	days	MEAN
SECONDARY	Apparent Volume of Distribution at Steady State	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis	mL	MEDIAN
SECONDARY	Terminal Half-life	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis	days	MEDIAN
SECONDARY	Maximum Plasma Concentration (Cmax)	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis	mg/mL	MEDIAN
SECONDARY	Time to Maximum α1-PI Concentration Post-infusion (Tmax)	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis	days	MEDIAN
SECONDARY	Incremental Recovery	Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion	Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis	(mg/mL) / (mg/kg)	MEDIAN
SECONDARY	Adverse Events (AEs)	Throughout study period (7 months)	Safety Analysis Data Set - all study subjects who had evidence of receiving at least one dose of study medication regardless of any protocol violation.	Events	NUMBER

Source ClinicalTrials.gov

Results by group26

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

Outcome	Group	Value	Spread	Units
Area Under the Curve/Dose	ARALAST Fr. IV-1	0.0822	Full Range 0.0750 to 0.094	days*kg/mL
Area Under the Curve/Dose	ARALAST	0.0920	Full Range 0.0804 to 0.098	days*kg/mL
Total Area Under the Curve Per Dose	ARALAST Fr. IV-1	0.0825	Full Range 0.0750 to 0.095	days*kg/mL
Total Area Under the Curve Per Dose	ARALAST	0.0928	Full Range 0.0812 to 0.099	days*kg/mL
Systemic Clearance (CL)	ARALAST Fr. IV-1	951	Full Range 782 to 1115	mL/day
Systemic Clearance (CL)	ARALAST	856	Full Range 782 to 918	mL/day
Mean Residence Time (MRT)	ARALAST Fr. IV-1	6.8	Standard Deviation 3.9	days
Mean Residence Time (MRT)	ARALAST	6.9	Standard Deviation 2.8	days
Apparent Volume of Distribution at Steady State	ARALAST Fr. IV-1	5606	Full Range 4624 to 6162	mL
Apparent Volume of Distribution at Steady State	ARALAST	5405	Full Range 4454 to 6703	mL

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Period 1	STARTED	ARALAST Fr. IV-1 Then Aralast	14
Period 1	STARTED	ARALAST Then ARALAST Fr. IV-1	11
Period 1	COMPLETED	ARALAST Fr. IV-1 Then Aralast	14
Period 1	COMPLETED	ARALAST Then ARALAST Fr. IV-1	11
Period 1	NOT COMPLETED	ARALAST Fr. IV-1 Then Aralast	0
Period 1	NOT COMPLETED	ARALAST Then ARALAST Fr. IV-1	0
Period 2	STARTED	ARALAST Fr. IV-1 Then Aralast	14
Period 2	STARTED	ARALAST Then ARALAST Fr. IV-1	11
Period 2	COMPLETED	ARALAST Fr. IV-1 Then Aralast	14
Period 2	COMPLETED	ARALAST Then ARALAST Fr. IV-1	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events28

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	Nausea	Gastrointestinal disorders	ARALAST Fr. IV-1	2	25	2
other	Nausea	Gastrointestinal disorders	ARALAST	3	25	3
other	Vessel puncture site bruise	General disorders	ARALAST Fr. IV-1	3	25	3
other	Vessel puncture site bruise	General disorders	ARALAST	2	25	6
other	Nasopharyngitis	Infections and infestations	ARALAST Fr. IV-1	2	25	2
other	Nasopharyngitis	Infections and infestations	ARALAST	1	25	1
other	Upper respiratory tract infection	Infections and infestations	ARALAST Fr. IV-1	3	25	3
other	Upper respiratory tract infection	Infections and infestations	ARALAST	1	25	1
other	Contusion	Injury, poisoning and procedural complications	ARALAST Fr. IV-1	0	25	0
other	Contusion	Injury, poisoning and procedural complications	ARALAST	3	25	4

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ARALAST Fr. IV-1
Total, all-cause mortality	ARALAST
Total, other adverse events	ARALAST Fr. IV-1	23	25
Total, other adverse events	ARALAST	19	25
Total, serious adverse events	ARALAST Fr. IV-1	0	25
Total, serious adverse events	ARALAST	0	25

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 comparisons1

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

Comparison
ARALAST Fr. IV-1 vs ARALAST: 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/NCT00242385

GET https://conductscience.org/api/trials/v1/NCT00242385/results?page=2

API reference For AI assistants