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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00157092 | Study of the Effect of Aerosolized, Recombinant Alpha 1-Antitrypsin on Epithelial Lining Fluid Analytes in Subjects With Alpha 1-Antitrypsin Deficiency | PHASE1 | COMPLETED | 15 | — | — | Mar 1, 2004 | Oct 14, 2004 | May 5, 2021 | 1 | United States |
| NCT00161707 | Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency | PHASE1 | COMPLETED | 40 | — | — | Jan 7, 2003 | Oct 1, 2003 | May 5, 2021 | 4 | United States |
| Name | Type | Description |
|---|---|---|
| Aerosolized, Recombinant Alpha 1-Antitrypsin | DRUG | - |
Inclusion Criteria: * Signed Informed Consent * Male or female 18 years of age or older * Documented, endogenous plasma AAT levels \< 11 µM (\< 80 mg/dL), either obtained from the medical history or, if not documented, plasma AAT measured after 28 day washout of any prior replacement therapy * Forc...