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
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