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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04159831 | A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions | PHASE2 | COMPLETED | 44 | — | — | Sep 26, 2020 | Jul 28, 2022 | Mar 30, 2023 | 33 | United States |
Treatment failure, as evidenced by continued or worsening pleural sepsis and failure to adequately drain pleural effusion, resulting in referral to surgery
| Arm | Type | Description |
|---|---|---|
| 400,000 U LTI-01 | EXPERIMENTAL | 400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally |
| 800,000 U LTI-01 | EXPERIMENTAL | 800,000 U LTI-01 qd x 3 days administered intrapleurally |
| 1,200,000 U LTI-01 | EXPERIMENTAL | 1,200,000 U LTI-01 qd x 3 days administered intrapleurally |
| Placebo | PLACEBO_COMPARATOR | placebo (normal saline) 6ml qd x 3 days administered intrapleurally |
| Name | Type | Description |
|---|---|---|
| LTI-01 | DRUG | single-chain urokinase plasminogen activator, scuPA |
| Placebo | DRUG | normal saline |
Key Inclusion Criteria: * Male or female ≥ 18 years of age who provide written informed consent * Clinical presentation compatible with complicated parapneumonic pleural effusion (CPE), empyema or other type of pleural infection * Has pleural fluid requiring drainage as determined by chest ultrason...