ARALAST SUMMARY
Alpha1-Proteinase Inhibitor (Human), Aralast™, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor ((alpha) 1-PI), also known as alpha1-antitrypsin.1
Alpha1-Proteinase Inhibitor (Human), Aralast™, is indicated for chronic augmentation therapy in patients having congenital deficiency of (alpha)1-PI with clinically evident emphysema. Clinical and biochemical studies have demonstrated that with such therapy, Aralast™ is effective in maintaining target serum (alpha)1-PI trough levels and increasing (alpha)1-PI levels in epithelial lining fluid (ELF). Clinical data demonstrating the long-term effects of chronic augmentation or replacement therapy of individuals with Aralast™ are not available.
Safety and effectiveness in pediatric patients have not been established. Aralast™ is not indicated as therapy for lung disease patients in whom congenital (alpha)1-PI deficiency has not been established.
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NEWS HIGHLIGHTS
Published Studies Related to Aralast ( Alpha 1-Antitrypsin)
Exploring the role of CT densitometry: a randomised study of augmentation therapy in alpha1-antitrypsin deficiency. [2009.06]
Assessment of emphysema-modifying therapy is difficult, but newer outcome measures offer advantages over traditional methods. The EXAcerbations and Computed Tomography scan as Lung End-points (EXACTLE) trial explored the use of computed tomography (CT) densitometry and exacerbations for the assessment of the therapeutic effect of augmentation therapy in subjects with alpha(1)-antitrypsin (alpha(1)-AT) deficiency...
Prevalence of alpha-1 antitrypsin deficiency in poorly controlled asthma--results from the ALA-ACRC low-dose theophylline trial. [2007.10]
In a study comparing low-dose theophylline to montelukast in poorly controlled asthmatics, 285 subjects consented to be screened for alpha-1 antitrypsin deficiency. Of the 284 for which complete data was available, 10.5% carried a deficiency gene and 2.4% were mildly deficient with an alpha-1 antitrypsin serum level of less than 20 mu M...
Alpha-1-antitrypsin replacement therapy: current status. [2006.03]
PURPOSE OF REVIEW: Alpha-1-antitrypsin deficiency is a relatively common genetic disease that predisposes to the development of early-onset emphysema and, in some instances, liver disease. The use of alpha-1-antitrypsin replacement therapy in the treatment of alpha-1-antitrypsin deficiency related emphysema is much debated and the purpose of this review is to examine the results of recent studies...
Multi-center study: the biochemical efficacy, safety and tolerability of a new alpha1-proteinase inhibitor, Zemaira. [2006.03]
Augmentation therapy with a plasma derived alpha l-Proteinase Inhibitor (alpha1 -PI) has been demonstrated to be effective in restoring serum Alpha1 -antitrypsin (AAT)* levels in individuals with AAT Deficiency (note: alpha1 PI and AAT are synonymous)... These results demonstrate that the new plasma derived alpha1-PI (Zemaira) is bioequivalent to the currently available product Prolastin, is well tolerated, and safe with respect to the risk of viral transmission.
Safety and efficacy of recombinant alpha(1)-antitrypsin therapy in cystic fibrosis. [2006.02]
Neutrophil elastase (NE) is thought to be the most important protease which damages the cystic fibrosis (CF) lung.
Clinical Trials Related to Aralast ( Alpha 1-Antitrypsin)
Pharmacokinetic Study of Aralast (Human Alpha1- PI) [Completed]
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 (Alpha1-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.
Aralast alpha1-Proteinase Inhibitor Surveillance Study [Active, not recruiting]
The primary objectives of this Phase 4, open label, prospective U. S. surveillance study are
to evaluate the health outcomes of AAT-deficient subjects who are initiating treatment with
ARALAST on patient-related outcomes (PRO), i. e., health-related quality of life (HRQoL),
healthcare resource utilization (HCRU), and various laboratory analyses to evaluate the
safety of long-term administration of ARALAST.
Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every
6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw
portion of the study, which will also include assessments of antibodies to ARALAST, and
chemistry panel. Subjects will be treated according to the prescribing (attending)
physician's instructions based on the prescribing information given in the ARALAST package
insert.
Efficacy and Safety Study of Augmentation Therapy With Aralast (Human Alpha 1 - Proteinase Inhibitor) [Completed]
The purpose of this study is to evaluate the effects of weekly augmentation therapy with
ARALAST Fr IV-1 on epithelial lining fluid (ELF) alpha 1-proteinase inhibitor levels and
other ELF analytes and to assess the safety of the treatment. Eligible subjects with a
diagnosis of severe congenital alpha 1-antitrypsin deficiency will receive 8 consecutive
weekly treatments with 60 mg/kg/week of functional ARALAST Fr IV-1 administered
intravenously. The efficacy and safety assessments will include two bronchoscopies with
bronchoalveolar lavage on study initiation and on study termination and multiple imaging and
laboratory safety assessments. Each subject will participate for a minimum of 12 weeks.
Deposition of Inhaled Prolastin in Cystic Fibrosis Patients [Completed]
The objective of this trial is to determine the optimal region of the lung for depositing
Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF).
The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either
the deep lung or to the upper airways in a one to one randomization. The study will measure
how much of the activity of the enzyme elastase is inhibited by AAT.
The Comparison of the Pharmacokinetic, Safety and Tolerability of Alpha-1 MP and Prolastin in Adult alpha1-Antitrypsin Deficient Patients. [Completed]
The purpose of this clinical study (ChAMP - Comparability pHarmacokinetics of Alpha-1
Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1
Proteinase Inhibitor (Human), modified process (Alpha-1 MP)and Prolastin in adult
Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug
on a weekly schedule for 24 weeks.
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