Pharmacokinetic Study of ARALAST (Human Alpha1- PI)

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Brief Title

Pharmacokinetic Study of ARALAST (Human Alpha1- PI)

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

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 Alpha1- Proteinase Inhibitor (α1-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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Area Under the Curve/Dose

Secondary Outcome

 Total Area Under the Curve Per Dose

Condition

Alpha 1-Antitrypsin Deficiency

Intervention

Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor

Study Arms / Comparison Groups

 ARALAST Fr. IV-1
Description:  60 mg/kg

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

25

Start Date

December 2005

Completion Date

June 2006

Primary Completion Date

June 2006

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jeff Garrett, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00242385

Organization ID

460501


Responsible Party

Sponsor

Study Sponsor

Baxalta now part of Shire

Collaborators

 Baxter Healthcare, Ltd. (New Zealand), Baxter Healthcare Pty. Ltd. (Australia)

Study Sponsor

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


Verification Date

April 2020