Phase 1
N=25
Pharmacokinetic Study of ARALAST (Human Alpha1- PI)
Alpha 1-Antitrypsin Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT00242385 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Area Under the Curve/Dose — 0.0822; 0.0920 days*kg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor (Biological); Dose of 60 mg/kg alpha1-proteinase inhibitor (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baxalta now part of Shire
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve/Dose |
0.0822; 0.0920 | — |
| SECONDARY Total Area Under the Curve Per Dose |
0.0825; 0.0928 | — |
| SECONDARY Systemic Clearance (CL) |
951; 856 | — |
| SECONDARY Mean Residence Time (MRT) |
6.8; 6.9 | — |
| SECONDARY Apparent Volume of Distribution at Steady State |
5606; 5405 | — |
| SECONDARY Terminal Half-life |
4.1; 4.2 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) |
1.7; 1.7 | — |
| SECONDARY Time to Maximum α1-PI Concentration Post-infusion (Tmax) |
0.00; 0.00 | — |
| SECONDARY Incremental Recovery |
0.0259; 0.0258 | — |
| SECONDARY Adverse Events (AEs) |
0; 0; 43; 45; 16; 12 | — |
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.
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 = 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
Data sourced from ClinicalTrials.gov (NCT00242385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.