Status:
COMPLETED
Pharmacokinetic Study of ARALAST (Human Alpha1- PI)
Lead Sponsor:
Baxalta now part of Shire
Collaborating Sponsors:
Baxter Healthcare, Ltd. (New Zealand), Baxter Healthcare Pty. Ltd. (Australia)
Conditions:
Alpha 1-Antitrypsin Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 Alp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00242385
Start Date
December 20 2005
End Date
June 5 2006
Last Update
May 13 2021
Active Locations (7)
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1
Adelaide, South Australia, Australia
2
Woodville, South Australia, Australia
3
Fitzroy, Victoria, Australia
4
Nedlands, Western Australia, Australia