Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Grifols Therapeutics Inc. Grifols Therapeutics LLC
Treatments:
Alpha 1-Antitrypsin Protease Inhibitors Protein C Inhibitor