PMID- 17175661
OWN - NLM
STAT- MEDLINE
DCOM- 20070109
LR  - 20191110
IS  - 1541-2555 (Print)
IS  - 1541-2563 (Linking)
VI  - 3
IP  - 1
DP  - 2006 Mar
TI  - Multi-center study: the biochemical efficacy, safety and tolerability of a new 
      alpha1-proteinase inhibitor, Zemaira.
PG  - 17-23
AB  - 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). The objective of this study was to demonstrate that the steady-state 
      trough serum alphal-PI levels, achieved by a new plasma derived alpha,-PI 
      (Zemaira, study drug, ZLB Behring LLC, King of Prussia, Pennsylvania, USA), were 
      bioequivalent to those achieved by the currently available alpha-PI therapy, 
      Prolastin (control drug, Bayer Corporation, Berkeley, California, USA), and 
      maintained weekly trough serum antigenic alpha1-PI levels above the protective 
      threshold of 11 microM. This multi-center, controlled study randomized a total of 
      44 subjects to receive either study or control drug for a 10-week double-blind 
      phase. The control group was then crossed over to receive the study drug for the 
      remainder of the study (14 weeks). The difference in mean trough serum antigenic 
      alpha1-PI level between the treatment groups was 1.45 microM (90% CI-2.77, 
      -0.13), signifying bioequivalence. The mean trough serum antigenic alpha1-PI 
      level in the study drug group was greater than the therapeutic threshold of 11 
      microM, achieving a level of 17.7 microM during the steady-state period. 
      Treatment-related adverse events (AEs) were seen in 7% and 21% of study and 
      control drug treated subjects, respectively. No documented viral transmission 
      occurred. 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.
FAU - Stocks, James M
AU  - Stocks JM
AD  - The University of Texas Health Center at Tyler, 11937 US Hwy 271, Tyler, TX 
      75708-3154, USA.
FAU - Brantly, Mark
AU  - Brantly M
FAU - Pollock, David
AU  - Pollock D
FAU - Barker, Alan
AU  - Barker A
FAU - Kueppers, Friedrich
AU  - Kueppers F
FAU - Strange, Charlie
AU  - Strange C
FAU - Donohue, James F
AU  - Donohue JF
FAU - Sandhaus, Robert
AU  - Sandhaus R
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - COPD
JT  - COPD
JID - 101211769
RN  - 0 (Serine Proteinase Inhibitors)
RN  - 0 (alpha 1-Antitrypsin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Cross-Over Studies
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Serine Proteinase Inhibitors/blood/pharmacokinetics/*therapeutic use
MH  - Therapeutic Equivalency
MH  - alpha 1-Antitrypsin/blood/pharmacokinetics/*therapeutic use
MH  - alpha 1-Antitrypsin Deficiency/blood/*drug therapy
EDAT- 2006/12/21 09:00
MHDA- 2007/01/11 09:00
CRDT- 2006/12/21 09:00
PHST- 2006/12/21 09:00 [pubmed]
PHST- 2007/01/11 09:00 [medline]
PHST- 2006/12/21 09:00 [entrez]
AID - 10.1080/15412550500493220 [doi]
PST - ppublish
SO  - COPD. 2006 Mar;3(1):17-23. doi: 10.1080/15412550500493220.