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Talecris testing higher dose of Prolastin-C for Alpha-1

PR Newswire
RESEARCH TRIANGLE PARK, N.C — Talecris Biotherapeutics, Inc. has begun a clinical trial of two doses of Polastin®-C, a therapy indicated for chronic augmentation and maintenance in adults with emphysema due to Alpha-1 Antitrypsin Deficiency.

This study will investigate the safety and pharmacokinetic profile of a higher dose, 120 mg/kg weekly, of Prolastin-C versus the licensed dose of 60 mg/kg weekly.

Subjects in the study will be randomized to receive either the 120 mg/kg dose or the 60 mg/kg dose for 8 weeks. They will then cross over to the alternate dose for an additional 8 weeks. The study will be conducted at five sites across the United States. Further information regarding this ongoing study can be found on ClinicalTrials.gov (study identifier NCT01213043).

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