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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00879606 | Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome | PHASE2 | COMPLETED | 150 | — | — | Apr 1, 2009 | Jan 1, 2013 | Apr 10, 2015 | 20 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Participants will be randomized to receive ALT-836. |
| 2 | PLACEBO_COMPARATOR | Patients will be randomized to receive placebo. |
| Name | Type | Description |
|---|---|---|
| ALT-836 | DRUG | In the first part of this study, recombinant chimeric anti-tissue factor antibody ALT-836 was administered as a single dose (0.06 mg/Kg) via intravenous infusion over 15 minutes. In the second part of this study, up to four doses (0.06 mg/Kg) of ALT-836 will be administered via intravenous infusion over 15 minutes. |
| Placebo | DRUG | In the first part of this study, a single dose of Placebo was administered via intravenous infusion over 15 minutes. In the second part of this study, up to four doses of Placebo will be administered via intravenous infusion over 15 minutes. |
INCLUSION CRITERIA: 1. Suspected or proven infection 2. Hypoxemia: PaO2/FiO2is ≤300 mm Hg 3. Bilateral infiltrates consistent with pulmonary edema 4. Positive-pressure mechanical ventilation through an endotracheal tube 5. No clinical evidence of left atrial hypertension to explain bilateral infilt...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | — | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | — | Undisclosed |
| Danaher Corporation | DHR | 3 | — | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | NA | Undisclosed |