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A Study of IL-7 to Restore Absolute Lymphocyte Counts in Sepsis Patients

NCT02640807 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-07-09

Study results available
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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.

Conditions

  • Severe Sepsis With Septic Shock

Interventions

DRUG

Interleukin-7

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Vanderbilt University School of Medicine

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Revimmune

    lead INDUSTRY

Principal Investigators

  • Edward SHERWOOD, MD, PhD · Vanderbilt University Medical Center

  • Richard HOTCHKISS, MD, PhD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-08-27
Completion
2018-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02640807 on ClinicalTrials.gov