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GR270773- Phospholipid emulsion

Phase 2

Sepsis | Small molecule | Infectious Disease |GSK plc|Last Updated: Sep 25, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment1,431

FDA Designations

No designations recorded

Clinical trial landscape

GR270773- Phospholipid emulsion · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT00089986GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In AdultsSepsis
COMPLETED1,415 Analytics
PHASE2COMPLETED
GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
SepsisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With 28-Day All Cause Mortality
Day 1 (post-infusion) up to Day 28 Follow-up

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 Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint.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.

Compare drug concentrations in the blood between patients with impaired liver function and normal healthy adults, after 72 hours. Determine whether administration of study drug alters the lipid make-up of healthy adults in any way.
Up to Day 16

Secondary Endpoints

Number of Participants With New Onset Organ Failure, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrolment
Baseline (Day 1, pre-infusion) up to Day 28 Follow-up
Number of Participants With New Onset Organ Failure of Respiratory Failure, Cardiovascular Failure, Renal Failure and Coagulopathy, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrollment
Baseline (Day 1, pre-infusion) up to Day 28 Follow up
Assessment of Safety/Tolerability by Determining the Number of Participants With Any Adverse Events (AE), Serious Adverse Events (SAE) and Fatal SAE
Day 1 (pre-infusion) up to Day 28 Follow-up
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Study Design & Arms

AllocationRANDOMIZED
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects with moderate hepatic impairmentEXPERIMENTALSubjects 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 subjectsEXPERIMENTALSubjects 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.

Interventions

NameTypeDescription
Intravenous GR270773- Phospholipid EmulsionDRUG -
PlaceboOTHER -
Intravenous GR270773 - Phospholipid emulsionDRUGGR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites390

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 ...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileCzechiaEstoniaFinlandFranceGermanyGreeceHong KongHungaryIndiaIsraelLatviaMalaysiaNetherlandsNew ZealandPortugalPuerto RicoRomaniaRussiaSloveniaSouth AfricaSouth KoreaSpainSwedenTaiwanThailandUnited KingdomSlovakia
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Frequently asked questions about GR270773- Phospholipid emulsion

What is GR270773 used for?

GR270773 is an investigational phospholipid emulsion being studied for the treatment of sepsis, specifically suspected or confirmed gram-negative severe sepsis in adults. It is a small molecule developed by GSK plc. The drug is currently in Phase 2 clinical development and is not approved for use.

Who is developing GR270773?

GR270773 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is an investigational small molecule in Phase 2 clinical trials for the treatment of sepsis.

What phase is GR270773 in?

GR270773 is in Phase 2 clinical development. It has completed two clinical trials, including a Phase 2 study in patients with suspected or confirmed gram-negative severe sepsis and a Phase 1 study in healthy adults and adults with liver damage. The drug remains investigational.

What clinical trials has GR270773 been in?

GR270773 has been studied in two completed clinical trials. The first, NCT00089986, was a Phase 2 study enrolling 1,415 adults with suspected or confirmed gram-negative severe sepsis. The second, NCT00158769, was a Phase 1 study enrolling 16 participants to compare the drug's effects in healthy adults versus those with liver damage.

Is GR270773 the same as a phospholipid emulsion?

Yes, GR270773 is a phospholipid emulsion. It is a small molecule drug being investigated for sepsis. The drug has been studied in clinical trials for the treatment of suspected or confirmed gram-negative severe sepsis in adults.