Pharmacokinetic Study of Aralast (Human Alpha1- PI) - Full Text View

Purpose

The primary purpose of this study is to characterize the pharmacokinetic profile of intravenous Aralast Fraction (Fr.) IV-1, a sterile, stable, lyophilized preparation of functionally intact human Alpha1- Proteinase Inhibitor (Alpha1-PI). This pharmacokinetic study will be a randomized controlled clinical trial with a cross-over design. Twenty-four subjects will be enrolled into the study. Overall study duration will be approximately 6-8 months.

Condition	Intervention	Phase
Alpha 1-Antitrypsin Deficiency	Drug: ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1)	Phase I

Genetics Home Reference related topics:

alpha-1 antitrypsin deficiency

MedlinePlus related topics:

Alpha-1 Antitrypsin Deficiency

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics Study

Official Title:	Single-Dose, Double-Blind, Crossover Study to Evaluate the Pharmacokinetic Comparability of ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1) and ARALAST

Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment:	24
Study Start Date:	December 2005
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject or subject´s legally authorized representative has provided written informed consent
Subject is 18 years of age or older
Subject has a documented, endogenous plasma Alpha1-PI level < 8 Micromolar
Subject is of the genotype Pi*Z/Z, Pi*Z/Null, Pi*Null/Null, Pi*Malton/Z, or others, dependent on the approval by the Sponsor
If the subject is female or of childbearing potential, the subject has a negative urine test for pregnancy within 7 days prior to first study product administration and agrees to employ adequate birth control measures for the duration of the study
Laboratory results obtained at the screening visit, meeting the following criteria:
- Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 2 times the upper limit of normal (ULN)
- Serum total bilirubin <= 2 times ULN
- Proteinuria < +2 on dipstick analysis
- Serum creatinine <= 1.5 times ULN
- Absolute neutrophil count (ANC) >= 1500 cells/mm3
- Hemoglobin >= 10.0 g/dL
- Platelet count >= 10^5/mm3
If the subject is treated with any respiratory medications, including inhaled bronchodilators and inhaled or oral corticosteroids, the subjects´ medication doses were unchanged for at least 14 days prior to first study product administration
Nonsmoker for a minimum of 3 months prior to first study product administration

Exclusion Criteria:

The subject has received any Alpha1-PI augmentation therapy (including Aralast and investigational Alpha1-PIs, by any route including intravenous and inhaled) within 42 days prior to first study product administration
The subject has received an investigational drug or device within 1 month prior to first study product administration, or the subject is currently receiving an investigational drug
The subject has a known selective immunoglobulin A (IgA) deficiency (IgA level < 15 mg/dL) and/or antibody to IgA
The subject has a pulmonary exacerbation or had a pulmonary exacerbation in the past 14 days prior to first study product administration
The subject is pregnant or lactating, or intends to become pregnant during the course of the study
The subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242385

Locations


Australia, South Australia
	The Queen Elizabeth Hospital
	Woodville, South Australia, Australia
	Royal Adelaide Hospital
	Adelaide, South Australia, Australia

Australia, Victoria
	St. Vincent´s Hospital
	Fitzroy, Victoria, Australia

Australia, Western Australia
	Sir Charles Gairdner Hospital
	Nedlands, Western Australia, Australia

New Zealand
	Christchurch Hospital, Canterbury Respiratory Research Group
	Christchurch, New Zealand
	Waikato Hospital, Respiratory Department
	Hamilton, New Zealand

New Zealand, Auckland
	Middlemore Hospital
	Otahuhu, Auckland, New Zealand

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators


Principal Investigator:	Jeff Garrett, MD	Middlemore Hospital, Otahuhu, Auckland, New Zealand

More Information

Study ID Numbers:	460501
First Received:	October 19, 2005
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00242385
Health Authority:	United States: Food and Drug Administration; Australia: Human Research Ethics Committee; New Zealand: Health and Disability Ethics Committees