Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02282527 | A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency | PHASE2 | COMPLETED | 32 | — | — | Oct 1, 2014 | Jan 1, 2016 | Mar 13, 2017 | 6 | United States |
The primary PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC0-7days) using an antigenic content assay of alpha₁-PI, at approximate steady state in subjects with AATD.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | OTHER | Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C |
| Treatment Sequence 2 | OTHER | Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI |
| Name | Type | Description |
|---|---|---|
| Liquid Alpha₁-PI | BIOLOGICAL | Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions |
| Prolastin-C | BIOLOGICAL | Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions |
Inclusion Criteria: * Be between 18 and 70 years of age, inclusive * Had a diagnosis of congenital AATD * Had a documented total alpha₁-PI level \< 11 µM. If the total alpha₁-PI level had yet to be documented, a blood draw for total alpha₁-PI level was obtained at the Screening Visit * Had a post-b...