CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Interleukin-7 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02640807
NCT02640807Phase 2Completed
CompareCT.gov

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.

Revimmune·interventional·Posted Dec 29, 2015·Updated Jul 9, 2020

In Brief

A Phase 2 clinical trial evaluating Interleukin-7 and Placebo for Severe Sepsis With Septic Shock. Completed, enrolled 27 participants across 1 site.

Detailed 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-7B (Immune Reconstitution of Immunosuppressed Sepsis patients). A parallel study will be performed in France to allow a common statistical analysis of the primary end points and analysis for the enrolled patient population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Sepsis With Septic Shock
CountriesUnited States
CollaboratorsVanderbilt University School of Medicine, Washington University School of Medicine

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 29, 2015
Enrollment StartJan 1, 2016
Primary CompletionAug 27, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.5 years ago

Interventions

Interleukin-7drug

IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) \>2.5 or platelet count \< 35,000

Placebodrug

IM administration of Placebo (SC administration for patients with INR\>2.5 or platelet count \< 35,000