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

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00242385

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: alpha-1 antitrypsin deficiency

MedlinePlus related topics: Alpha-1 Antitrypsin Deficiency

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Baxter Healthcare Corporation:

Severe congenital Alpha1-Proteinase Inhibitor (Alpha1-PI) deficiency

Study placed in the following topic categories:

Serine Proteinase Inhibitors
Protein C Inhibitor
Alpha 1-Antitrypsin
Alpha 1-Antitrypsin Deficiency

Connective Tissue Diseases
Alpha 1-antitrypsin Deficiency
Serine
Protease Inhibitors

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Alpha 1-Antitrypsin
Molecular Mechanisms of Pharmacological Action
Alpha 1-Antitrypsin Deficiency
Trypsin Inhibitors

Connective Tissue Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on July 02, 2009