CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor +1 morebiological
Likely dose
60 mg/kg intravenously at 0.2 mL/kg/min, single doseAI-extracted
Key inclusion· 5
  • ✓Age 18 years or older
  • ✓Documented plasma alpha-1 proteinase inhibitor level <8 μM
  • ✓Genotype Pi*Z/Z, Pi*Z/Null, Pi*Null/Null, Pi*Malton/Z, or other sponsor-approved genotypes
  • ✓Nonsmoker for minimum 3 months prior to study
Key exclusion· 6
  • ✕Alpha-1 proteinase inhibitor augmentation therapy within 42 days
  • ✕Investigational drug or device within 1 month or currently receiving
  • ✕Known selective IgA deficiency (IgA <15 mg/dL) and/or anti-IgA antibodies
  • ✕Pulmonary exacerbation within past 14 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00242385
NCT00242385Phase 1Completed
CompareCT.gov

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

Baxalta now part of Shire·interventional·Posted Oct 20, 2005·Updated May 13, 2021

In Brief

A Phase 1 clinical trial evaluating Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor and Dose of 60 mg/kg alpha1-proteinase inhibitor for Alpha 1-Antitrypsin Deficiency. Completed, enrolled 25 participants across 7 sites in 2 countries.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha 1-Antitrypsin Deficiency
CountriesAustralia, New Zealand
CollaboratorsBaxter Healthcare, Ltd. (New Zealand), Baxter Healthcare Pty. Ltd. (Australia)

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 20, 2005
Enrollment StartDec 20, 2005
Primary CompletionJun 5, 2006
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.7 years ago

Interventions

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

Subjects meeting the eligibility criteria were randomized to receive either single dose ARALAST alpha1-proteinase inhibitor 60 mg/kg or single-dose ARALAST alpha1-proteinase inhibitor Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.

Dose of 60 mg/kg alpha1-proteinase inhibitorbiological

Subjects meeting the eligibility criteria were randomized to receive either single dose ARALAST alpha1-proteinase inhibitor 60 mg/kg or single-dose ARALAST alpha1-proteinase inhibitor Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.