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Pharmacokinetic Study of Aralast (Human Alpha1- PI)

Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alpha 1-Antitrypsin Deficiency

Intervention: ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Baxter Healthcare Corporation

Official(s) and/or principal investigator(s):
Jeff Garrett, MD, Principal Investigator, Affiliation: Middlemore Hospital, Otahuhu, Auckland, New Zealand

Summary

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.

Clinical Details

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics Study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Christchurch Hospital, Canterbury Respiratory Research Group, Christchurch, New Zealand

Waikato Hospital, Respiratory Department, Hamilton, New Zealand

Middlemore Hospital, Otahuhu, Auckland, New Zealand

The Queen Elizabeth Hospital, Woodville, South Australia, Australia

Royal Adelaide Hospital, Adelaide, South Australia, Australia

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

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

Additional Information

Starting date: December 2005
Ending date: June 2006
Last updated: October 31, 2006

Page last updated: June 20, 2008

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