drugset / Trial / NCT01649921

The Effects of Interferon-gamma on Sepsis-induced Immunoparalysis

NCT01649921

Phase 3 Completed 4 enrolled Radboud University Medical Center
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The primary aim of this study is to assess the effects of adjunctive therapy with Interferon (IFN)-gamma on immune function in patients with septic shock in a placebo-controlled manner. Moreover, the investigators want to evaluate new markers that could be used to identify patients with immunoparalysis, and to monitor the patient's immunological response to IFN-γ. In addition, mechanistic studies will be performed to further elucidate mechanisms (such as epigenetic modifications) behind immunoparalysis and the effects of IFN-γ on these mechanisms. With use of the results the investigators will obtain in this pilot study, the investigators will conduct a large multicentre clinical trial with IFN-γ.

Timeline

Start
2012-11
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator interferon gamma Protein / enzyme biologic 100 ug Subcutaneous