Status:
COMPLETED
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
Lead Sponsor:
Grifols Therapeutics LLC
Conditions:
Alpha 1-Antitrypsin Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (Huma...
Detailed Description
The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP to Prolastin® in subjects with Alpha1-antitrypsin deficiency. This study is divided into three 8-week tre...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00295061
Start Date
May 1 2006
End Date
February 1 2007
Last Update
September 9 2014
Active Locations (8)
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1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
2
University of Florida College of Medicine
Gainesville, Florida, United States, 32610-0225
3
University of Miami School of Medicine
Miami, Florida, United States, 33101
4
St Lukes-Roosevelt Hospital Center, New York
New York, New York, United States, 10019