Pharmacokinetic Study of ARALAST (Human Alpha1- PI)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00242385
• Date of registration: 19/10/2005
• Prospective Registration: Yes
• Primary sponsor: Baxalta now part of Shire
• Public title: Pharmacokinetic Study of ARALAST (Human Alpha1- PI)
• Scientific 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
• Date of first enrolment: December 2005
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00242385
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 1

Countries of recruitment

Australia, New Zealand

Contacts

• Name: Jeff Garrett, MD
• Affiliation: Middlemore Hospital, Otahuhu, Auckland, New Zealand

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Alpha 1-Antitrypsin Deficiency

Intervention(s)

Biological: Dose of 60 mg/kg alpha1-proteinase inhibitor

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

Primary Outcome(s)

Area Under the Curve/Dose [Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion]

Secondary Outcome(s)

Maximum Plasma Concentration (Cmax) [Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion]

Total Area Under the Curve Per Dose [Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion]

Adverse Events (AEs) [Time Frame: Throughout study period (7 months)]

Systemic Clearance (CL) [Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion]

Mean Residence Time (MRT) [Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion]

Time to Maximum a1-PI Concentration Post-infusion (Tmax) [Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion]

Apparent Volume of Distribution at Steady State [Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion]

Terminal Half-life [Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion]

Incremental Recovery [Time Frame: Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion]

Secondary ID(s)

460501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

Results

• Results available: Yes
• Date Posted: 20/07/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00242385