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CytoSorb hemoperfusion

Phase 3

Sepsis | Unknown | Infectious Disease |Cytosorbents Corporation|Last Updated: Dec 22, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04643639Assessing the Effects of CytoSorb Hemoperfusion on the Development on ImmunoparalysisPHASE3 COMPLETED 24Sep 16, 2020Oct 19, 2022Dec 22, 20221 Netherlands
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Study Endpoints
Primary Endpoints
Between group differences in plasma interleukin (IL)-6 levels during the second endotoxin challenge.
Samples will be obtained starting 1 hour prior until 8 hours after endotoxin administration

Blood samples will be obtained at predefined time points before, during and after endotoxin administration to assess plasma levels (in pg/mL) of circulating inflammatory mediatiors. To assess between group differences, the area under the curve (AUC) of the time concentration curve (expressed in arbitrary units) of each inflammatory mediator will be calculated.

Secondary Endpoints
Between group differences in plasma levels of other inflammatory cytokines during the second endotoxin challenge.
Samples will be obtained starting 1 hour prior until 8 hours after endotoxin administration
Between group differences in mHLA-DR expression
1 hour before, 3 hours after and 6 hours after endotoxin administration
Between group differences in norepinephrine sensitivity
One hour before and 4 hours after endotoxin administration during the first endotoxin challenge
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTAL -
ControlNO_INTERVENTION -
Interventions
NameTypeDescription
CytoSorb hemoperfusionDEVICESubjects will be treated with CytoSorb hemoperfusion (in stand-alone setup) for 6 hours at a flow rate of 250 ml/min during endotoxemia.
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Eligibility Criteria
Age Range18 Years — 35 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provide written informed consent * Male * Age ≥ 18 and ≤ 35 years * Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and routine clinical laboratory parameters) Exclusion Criteria: * Use of any medication * Smoking...

Countries:Netherlands
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