Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults

Completed · Phase 3

Conditions studied: Alpha 1-Antitrypsin Deficiency

In brief

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.

Key facts

Study ID

NCT00295061

Run by

Grifols Therapeutics LLC

People needed

24

Starts

2006-05-01

Expected to finish

2007-02-01

Last updated by the study team

2014-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of congenital Alpha1-antitrypsin deficiency
• Must be receiving augmentation therapy with plasma-derived (human) Alpha1-Proteinase Inhibitor (Prolastin®) for at least one month prior to study entry.
• Signed written informed consent prior to initiation of any study related procedures

You may not qualify if…

• Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling to practice adequate contraception throughout the study
• Use of systemic steroids within the 2 weeks prior to receiving study treatment (this does not include the use of inhaled steroids used on a routine or as needed basis).
• Subjects who have had exacerbations of their disease within one month of trial entry.

Where it is running

• National Jewish Medical and Research Center — Denver, Colorado, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• St Lukes-Roosevelt Hospital Center, New York — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Health Center at Tyler — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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