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Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts in Sepsis Patients — IRIS-7-C&D  

Sepsis, Severe Clinical Trial

Official title:
International, Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts (ALC) in Patients With Sepsis

Clinical Trial Summary

This phase II randomized study will assess the effect of receiving IV recombinant human IL-7 (CYT107) versus placebo in lymphopenic sepsis patients The aim is to confirm the immune cell reconstitution observed in other studies and other patient populations among which the IRIS-7 A&B study which was conducted in the same patient population.

Clinical Trial Description

Lymphopenic sepsis Patients will be randomized 3:1 to receive either: a) Intravenous (IV) administration of CYT107 at 10 μg/kg twice a week for 3 weeks or b) IV placebo (normal saline). The effect of CYT107 on Lymphocyte and various T cell populations will be documented with a focus on the first 29 days. Stopping rules will apply if ALC increases to >2.5 times the upper limit of normal range. The IRIS-7C & D studies will be conducted at multiple sites in France and the United States. All sites will use the same study design and similar study protocol for a common statistical analysis of 40 evaluable participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03821038
Study type Interventional
Source Revimmune
Contact
Status Terminated
Phase Phase 2
Start date June 1, 2019
Completion date October 6, 2021
View Details
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