At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Prolastin-C, 60 mg/kg +1 morebiological
Likely dose
Prolastin-C, 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.
A Randomized Double-blind Crossover Study to Assess the Safety and Pharmacokinetics of Two Different Doses of Weekly Intravenous Administration of Alpha1-Proteinase Inhibitor (Human) Prolastin®-C in Subjects With Alpha1-Antitrypsin Deficiency
In Brief
A Phase 2 clinical trial evaluating Prolastin-C, 60 mg/kg and Prolastin-C, 120 mg/kg for Emphysema and Alpha 1-antitrypsin Deficiency (AATD). Completed, enrolled 30 participants across 5 sites.
Detailed Summary
This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C (alpha1-proteinase inhibitor \[alpha1-PI\] \[Human\]), compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEmphysema, Alpha 1-antitrypsin Deficiency (AATD)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartNov 2010
Primary CompletionJan 2012
TodayJul 2026
First PostedOct 1, 2010
Enrollment StartNov 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.8 years ago
Interventions
Prolastin-C, 60 mg/kgbiological
60 mg/kg weekly infusion of Prolastin-C for 8 weeks
Prolastin-C, 120 mg/kgbiological
120 mg/kg weekly infusion of Prolastin-C for 8 weeks