drugset / Trial / NCT02797431

Immune Reconstitution of Immunosuppressed Sepsis Patients

NCT02797431

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in sepsis patients; IRIS-7A (Immune Reconstitution of Immunosuppressed Sepsis patients). A parallel study will be performed in United State of America to allow a common statistical analysis of the primary end points and analysis for the enrolled patient population.

Timeline

Start
2016-01-14
Primary completion
2017-03-21
Completion
2017-11-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Interleukin-7 Protein / enzyme biologic 10 ug/kg Intramuscular