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Also known as Intravenous GR270773 - Phospholipid emulsion
GR270773- Phospholipid emulsion · 2 trials · 1 indication
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 Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint.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 ...
Top 3 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
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| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Bayer | BAYRY | 2 | PHASE1 | BAY 3389934 |
GR270773- Phospholipid emulsion is an investigational small molecule developed for the treatment of sepsis, including suspected or confirmed Gram-negative severe sepsis in adults. It has been studied in Phase 2 clinical trials but is not approved for commercial use.
GR270773- Phospholipid emulsion is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK sponsored the clinical trials evaluating this agent in sepsis patients.
GR270773- Phospholipid emulsion is in Phase 2 clinical development. It has completed two trials, including a Phase 1 study and a Phase 2 study, but has not received FDA approval and remains investigational.
GR270773- Phospholipid emulsion has been evaluated in two completed clinical trials: NCT00158769, a Phase 1 study comparing its infusion effects between healthy adults and adults with damaged livers, and NCT00089986, a Phase 2 study in adults with suspected or confirmed Gram-negative severe sepsis.
Yes, GR270773- Phospholipid emulsion is also known as Intravenous GR270773- Phospholipid emulsion or Intravenous GR270773- Phospholipid Emulsion. These names refer to the same investigational agent developed by GSK for sepsis.