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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04204252 | Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation" | PHASE3 | RECRUITING | 220 | — | — | Nov 25, 2019 | Jun 1, 2031 | Sep 4, 2025 | 9 | Belgium, Finland +4 |
Change from baseline in post bronchodilator FEV1 at 104 weeks
| Arm | Type | Description |
|---|---|---|
| Inhaled AAT | ACTIVE_COMPARATOR | Daily inhalation of 80 mg/day "Kamada-AAT for Inhalation" for 104 weeks |
| Placebo | PLACEBO_COMPARATOR | Daily inhalation of a solution of NaCl in phosphate buffer solution with 0.01% TWEEN-80 |
| Name | Type | Description |
|---|---|---|
| Alpha 1-Antitrypsin | DRUG | Kamada's alpha 1-antitrypsin product given by inhalation using the eFlow® electronic nebulizer manufactured by PARI Pharma GmbH |
| Placebo | DRUG | Preparation of NaCl in phosphate buffer solution with 0.01% TWEEN-80 |
Inclusion Criteria 1. Diagnosis of severe AAT deficiency, i.e. patients with either Pi(ZZ), Pi(Z/Null), or Pi(Null/Null) genotypes. 2. Serum AAT levels ≤ 11 µM at screening. 3. Lung disease with clinical evidence of airflow limitation (post bronchodilator FEV1/SVC≤70%) at screening. 4. 40% ≤ FEV1 ≤...