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Pharmacokinetic Study of ARALAST (Human Alpha1- PI)

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Baxalta

Status and phase

Completed
Phase 1

Conditions

Alpha 1-Antitrypsin Deficiency

Treatments

Biological: Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor
Biological: Dose of 60 mg/kg alpha1-proteinase inhibitor

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

25 participants in 2 patient groups

ARALAST Fr. IV-1
Experimental group
Description:
60 mg/kg
Treatment:
Biological: Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor
ARALAST
Active Comparator group
Description:
60mg/kg
Treatment:
Biological: Dose of 60 mg/kg alpha1-proteinase inhibitor

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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