At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 32 enrolled
Drug / intervention
Liquid Alpha₁-PI +1 morebiological
Likely dose
Liquid Alpha₁-PI 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 Multi-center, Randomized, Double-blind, Crossover Study to Assess the Safety and Pharmacokinetics of Liquid Alpha₁-Proteinase Inhibitor (Human) Compared to Prolastin®-C in Subjects With Alpha₁-Antitrypsin Deficiency
In Brief
A Phase 3 clinical trial evaluating Liquid Alpha₁-PI and Prolastin-C for Alpha₁-Antitrypsin Deficiency. Completed, enrolled 32 participants across 6 sites.
Detailed Summary
Grifols Therapeutics Inc. conducted a multi-center, randomized, double-blind, crossover study to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha₁-PI compared to the currently licensed product, Prolastin-C, in subjects with Alpha₁-Antitrypsin Deficiency (AATD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha₁-Antitrypsin Deficiency
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedNov 2014
Primary CompletionJan 2016
TodayJul 2026
First PostedNov 4, 2014
Enrollment StartOct 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.7 years ago
Interventions
Liquid Alpha₁-PIbiological
Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions
Prolastin-Cbiological
Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions