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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00089986 | GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults | PHASE2 | COMPLETED | 1,415 | — | — | Sep 1, 2004 | Apr 15, 2007 | Aug 21, 2017 | 390 | United States, Argentina +32 |
| NCT00158769 | A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers | PHASE1 | COMPLETED | 16 | — | — | Mar 31, 2005 | Oct 26, 2005 | Sep 25, 2017 | 1 | Slovakia |
Mortality was assessed by the number of participants who died between days 1 and 28. A summary of death details was given which included whether the participant died between days 1 and 28, whether the death was related sepsis, cause of death, the source of the information, and whether the cause of death was verified by a death record. Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint. The difference in all-cause 28-day mortality rates for each treatment group versus the placebo group in the ITT Population was calculated as placebo - treatment.
| Arm | Type | Description |
|---|---|---|
| Subjects with moderate hepatic impairment | EXPERIMENTAL | Subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9 will be included. Subjects will be given GR270773 as a loading infusion of 25 milligram per kilogram per hour (mg/kg/hr) for 2 hours followed by a maintenance infusion of 5 mg/kg/hr for 70 hours. |
| Healthy subjects | EXPERIMENTAL | Subjects will be matched as closely as possible to the group of moderate hepatic subjects for gender, age and body mass index (BMI). Subjects will be administered 25 mg/kg/hr GR270773 as a loading dose for 2 hours followed by a maintenance infusion of 5 mg/kg/hr for 70 hours. Following a washout period of 21 days, the subjects will then receive a loading dose of 75 mg/kg/hr for 2 hours followed by a maintenance dose of 12.5 mg/kg/hr of GR270773 for 70 hours. |
| Name | Type | Description |
|---|---|---|
| Intravenous GR270773- Phospholipid Emulsion | DRUG | - |
| Placebo | OTHER | - |
| Intravenous GR270773 - Phospholipid emulsion | DRUG | GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection. |
Inclusion criteria: * Receiving parenteral antibiotic therapy for a suspected or confirmed Gram-negative infection. * Have at least one new hypoperfusion abnormality or at least one new onset organ failure resulting from the current septic episode. * Must be available and able to receive the first ...
| 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 |