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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02628600 | Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212 | PHASE3 | COMPLETED | 163 | — | — | Feb 5, 2016 | Oct 17, 2018 | Feb 10, 2020 | - | — |
TEAEs are defined as those AEs that occurred on or after the date of first dose of study medication in INS-312 and within 28 days after the last dose. If it couldn't be determined whether the AE is treatment emergent due to a partial onset date, then it was classified as treatment emergent.
| Arm | Type | Description |
|---|---|---|
| Prior LAI + Multidrug Regimen | EXPERIMENTAL | Participants in the prior Study INS-212 who received LAI+MDR. All participants in this safety extension study received LAI+MDR. |
| Prior Multidrug Regimen Alone | EXPERIMENTAL | Participants in the prior Study INS-212 who received MDR alone. All participants in this safety extension study received LAI+MDR. |
| Name | Type | Description |
|---|---|---|
| LAI 590 mg | DRUG | LAI 590 mg QD: administered by inhaling drug product that had been aerosolized in an investigational eFlow nebulizer over approximately 14 minutes |
| Multi-drug regimen | DRUG | Multidrug antimycobacterial regimen from study INS-212 |
Key Inclusion Criteria: 1. had successfully completed the Month 6 and End of Treatment visits in Study INS-212 2. had not achieved the INS-212 protocol definition of culture conversion by Month 6 in Study INS-212 OR had experienced a relapse or recurrence by Month 6 in Study INS-212. Key Exclusion...