Phase 3
N=24
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
Alpha 1-Antitrypsin Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT00295061 ↗Enrolled (actual)
24
Serious AEs
2.1%
Results posted
Sep 2014
Primary outcome: Primary: Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7 — 155.9; 152.4 mg*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Alpha-1 MP (Drug); alpha-1 proteinase inhibitor (human) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grifols Therapeutics LLC
- Primary completion
- Feb 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7 |
155.9; 152.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00295061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.