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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02001688 | Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation" | PHASE2 | COMPLETED | 36 | — | — | Apr 1, 2014 | May 1, 2016 | Jan 18, 2020 | 2 | United States |
Patients underwent bronchoalveolar lavage (BAL) prior to initiation of drug and then again after 3 months. Concentration of AAT in the BAL was measured by an enzyme linked immunosorbent assay (ELISA) specific for the normal form of AAT (piM). Urea was also measured in order to determine the dilution factor of the BAL fluid and calculate the concentration of AAT in the ELF.
ITT population with baseline and 12 week values. Patients underwent bronchoalveolar lavage (BAL) prior to initiation of drug and then again after 3 months. Concentration of AAT in the BAL was measured by an antineutrophil elastase capacity (ANEC) assay. Urea was also measured in order to determine the dilution factor of the BAL fluid and calculate the concentration of AAT in the ELF.
| Arm | Type | Description |
|---|---|---|
| Kamada-AAT for Inhalation, 80mg | EXPERIMENTAL | Daily inhalation of Kamada-AAT for Inhalation, 80mg |
| Placebo | PLACEBO_COMPARATOR | Placebo administered by inhalation daily |
| Kamada-AAT for Inhalation, 160mg | EXPERIMENTAL | Daily inhalation of Kamada-AAT for Inhalation, 160mg |
| Name | Type | Description |
|---|---|---|
| Kamada-AAT for Inhalation, 80mg | DRUG | - |
| Placebo | DRUG | - |
| Kamada-AAT for Inhalation, 160mg | DRUG | - |
Inclusion Criteria: * Male or female patients between 18 and 65 years of age (inclusive). * Able and willing to sign informed consent. * Males, and non-pregnant, non-lactating females whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investiga...