Trial · NCT02282527

A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency

NCT02282527, Phase 2, Phase 3, Completed, Grifols Therapeutics LLC; results first posted 2017-03-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency. Trials, record NCT02282527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02282527

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Trial

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

Title: A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency
NCT number: NCT02282527
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 32 participants, actual
Lead sponsor: Grifols Therapeutics LLC
Conditions: Alpha₁-Antitrypsin Deficiency
Interventions: Liquid Alpha₁-PI, Prolastin-C
First posted: 2014-11-04
Last updated: 2017-03-13
Results first posted: 2017-03-13

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	AUC(0-7 Days) Based on Antigenic Content	pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose	The primary PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC0-7days) using an antigenic content assay of alpha₁-PI, at approximate steady state in subjects with AATD.
Secondary	AUC(0-7 Days) Based on Functional Activity	pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose	The exploratory PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC 0-7 days) using a functional activity assay of alpha₁-PI, at approximate steady state in subjects with AATD.
Secondary	Number of Subjects With Immunogenicity Response	Weeks 1, 9, 17, and 20	Blood samples for immunogenicity testing were collected at Weeks 1 (Baseline), 9, 17, and 20. Any samples that tested positive for alpha₁-PI antibodies were tested for neutralizing antibodies and antibody titer. Immunogenicity testing was performed using validated assays in a multitiered approach. Samples collected at Week 1 (Baseline) and at Weeks 9 and 20 were tested for immunogenicity while samples collected at Week 17 were to be tested for immunogenicity only if deemed appropriate (eg, unexpected PK profile).

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	AUC(0-7 Days) Based on Antigenic Content	pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose	mg*h/mL	MEAN
SECONDARY	AUC(0-7 Days) Based on Functional Activity	pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose	mg*h/mL	MEAN
SECONDARY	Number of Subjects With Immunogenicity Response	Weeks 1, 9, 17, and 20	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
AUC(0-7 Days) Based on Antigenic Content	Liquid Alpha₁-PI	203.20	Standard Deviation 23.041	mg*h/mL
AUC(0-7 Days) Based on Antigenic Content	Prolastin-C	198.38	Standard Deviation 25.230	mg*h/mL
AUC(0-7 Days) Based on Functional Activity	Liquid Alpha₁-PI	171.16	Standard Deviation 28.764	mg*h/mL
AUC(0-7 Days) Based on Functional Activity	Prolastin-C	168.50	Standard Deviation 27.473	mg*h/mL
Number of Subjects With Immunogenicity Response	Liquid Alpha₁-PI/Prolastin-C	0		Participants
Number of Subjects With Immunogenicity Response	Prolastin-C/Liquid Alpha₁-PI	0		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Liquid Alpha₁-PI/Prolastin-C	16
Overall Study	STARTED	Prolastin-C/Liquid Alpha₁-PI	16
Overall Study	COMPLETED	Liquid Alpha₁-PI/Prolastin-C	15
Overall Study	COMPLETED	Prolastin-C/Liquid Alpha₁-PI	15
Overall Study	NOT COMPLETED	Liquid Alpha₁-PI/Prolastin-C	1
Overall Study	NOT COMPLETED	Prolastin-C/Liquid Alpha₁-PI	1

Source ClinicalTrials.gov

Adverse events12

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	Fatigue	General disorders	Liquid Alpha₁-PI	2	32	2
other	Fatigue	General disorders	Prolastin-C	0	31	0
other	Pyrexia	General disorders	Liquid Alpha₁-PI	2	32	2
other	Pyrexia	General disorders	Prolastin-C	0	31	0
other	Nasopharyngitis	Infections and infestations	Liquid Alpha₁-PI	1	32	1
other	Nasopharyngitis	Infections and infestations	Prolastin-C	2	31	2
other	Diarrhoea	Gastrointestinal disorders	Liquid Alpha₁-PI	2	32	3
other	Diarrhoea	Gastrointestinal disorders	Prolastin-C	1	31	1
other	Dermatitis Contact	Skin and subcutaneous tissue disorders	Liquid Alpha₁-PI	2	32	2
other	Dermatitis Contact	Skin and subcutaneous tissue disorders	Prolastin-C	0	31	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Liquid Alpha₁-PI
Total, all-cause mortality	Prolastin-C
Total, other adverse events	Liquid Alpha₁-PI	9	32
Total, other adverse events	Prolastin-C	3	31
Total, serious adverse events	Liquid Alpha₁-PI	0	32
Total, serious adverse events	Prolastin-C	1	31

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 comparisons2

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

Comparison	Source
Liquid Alpha₁-PI/Prolastin-C vs Prolastin-C/Liquid Alpha₁-PI: Number of Subjects With Immunogenicity Response	Trial comparisons
Liquid Alpha₁-PI vs Prolastin-C: serious adverse events	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/NCT02282527

GET https://conductscience.org/api/trials/v1/NCT02282527/registered

API reference For AI assistants