ZEMAIRA SUMMARY
Alpha1-Proteinase Inhibitor (Human), Zemaira™, is a sterile, stable, lyophilized preparation of highly purified human alpha1-proteinase inhibitor (A1-PI), also known as alpha1-antitrypsin, derived from human plasma. Zemaira™ is manufactured from large pools of human plasma by cold ethanol fractionation according to a modified Cohn process followed by additional purification steps.
Zemaira™ is indicated for chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema.
Zemaira™ increases antigenic and functional (ANEC) serum levels and lung epithelial lining fluid levels of A1-PI.
Clinical data demonstrating the long-term effects of chronic augmentation therapy of individuals with Zemaira™ are not available.
Safety and effectiveness in pediatric patients have not been established.
Zemaira™ is not indicated as therapy for lung disease patients in whom severe congenital A1-PI deficiency has not been established.
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NEWS HIGHLIGHTS
Published Studies Related to Zemaira (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 Zemaira (Alpha 1-Antitrypsin)
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.
Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency [Completed]
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the
short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha
1-antitrypsin deficiency. The subjects are randomized to receive placebo or one of 4 doses of
rAAT. The 4 doses are tested in a consecutive manner from lowest to highest.
Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients [Completed]
The goal of this trial was to explore the utility of evaluating emphysema progression through
CT scans measuring lung density during a 2 year period of weekly infusions of either placebo
or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries
were also collected. All efficacy data were analyzed for potential use in evaluating
Prolastin efficacy in this and other clinical trials.
The Safety and Tolerability of Alpha-1 MP in Subjects With Alpha-1-Antitrypsin (AAT) Deficiency. [Completed]
Study of the Effect of Aerosolized, Recombinant Alpha 1-Antitrypsin on Epithelial Lining Fluid Analytes in Subjects With Alpha 1-Antitrypsin Deficiency [Completed]
The study was a Phase 1B/2A, uncontrolled, open-label, single-center study in individuals
with congenital AAT (alpha 1-antitrypsin) deficiency. A baseline bronchoscopy with
bronchoalveolar lavage (BAL) was performed 3 to a maximum of 4 weeks prior to the first
administration of study drug. Fifteen eligible subjects were randomized to receive 1 of 3
dosing regimens of rAAT (100 mg daily, 100 mg twice daily, or 200 mg daily) administered via
nebulization for 7 consecutive days. A post-treatment nadir BAL was obtained on study Day 8
(12 hours after last dose for subjects who receive drug therapy twice daily and 24 hours
after the last dose for subjects who receive study product daily). BALs were conducted in the
same lung lobe/segment. Follow-up visits took place on Day 15 and Day 36.
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