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10% Hemohes

Phase 3

Severe Sepsis | Small molecule | Infectious Disease |Novo Nordisk A/S|Last Updated: Feb 11, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

10% Hemohes · 1 trial · 2 indications

Phase 3 1
NCT00135473Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)Severe Sepsis
COMPLETED600 Analytics
PHASE3COMPLETED
Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)
Severe SepsisUnlock trial analytics

Study Endpoints

Primary Endpoints

Mortality (28 day)
Morbidity (mean sepsis-related organ failure assessment [SOFA] score during intensive care unit length of stay [ICU LOS])

Secondary Endpoints

Frequency of acute kidney failure
Time until hemodynamic stabilization
Frequency of therapy with vasopressors (in days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Interventions

NameTypeDescription
10% Hemohes® (10% Hydroxyethyl starch)DRUG -
Sterofundin® (Ringer lactate solution)DRUG -
Actrapid® (Insulin)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission Exclusion Criter...

Countries:Germany
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Frequently asked questions about 10% Hemohes

What is 10% Hemohes used for in severe sepsis?

10% Hemohes is an investigational small molecule being studied for the treatment of severe sepsis. It is a volume substitute evaluated in the VISEP trial, which enrolled 600 patients with severe sepsis or septic shock. The drug is still in clinical development and has not been approved.

Who makes 10% Hemohes?

10% Hemohes is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the stock exchange under the ticker NVO. The company is conducting clinical research on this drug for severe sepsis.

What phase is 10% Hemohes in?

10% Hemohes is in Phase 3 clinical development. It has completed one Phase 3 trial, the VISEP trial, which enrolled 600 patients. The drug remains investigational and is not yet approved for any use.

What clinical trials is 10% Hemohes in?

10% Hemohes has been studied in one completed Phase 3 trial, NCT00135473, titled "Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsis (VISEP Trial)." This trial enrolled 600 patients with severe sepsis or septic shock in Germany.

Is 10% Hemohes FDA approved?

10% Hemohes is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for severe sepsis. The completed VISEP trial did not lead to approval, and the drug remains under study.