At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 24 enrolled
Drug / intervention
Alpha-1 MP +1 moredrug
Likely dose
Alpha-1 MP 60 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency.
In Brief
A Phase 3 clinical trial evaluating Alpha-1 MP and alpha-1 proteinase inhibitor (human) for Alpha 1-Antitrypsin Deficiency. Completed, enrolled 24 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha 1-Antitrypsin Deficiency
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2006
Enrollment StartMay 2006
Primary CompletionFeb 2007
TodayJul 2026
First PostedFeb 22, 2006
Enrollment StartMay 1, 2006
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 20.4 years ago
Interventions
Alpha-1 MPdrug
alpha-1 proteinase inhibitor (human), 60 mg/kg body weight
alpha-1 proteinase inhibitor (human)drug
Prolastin