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Immune Reconstitution of Immunosuppressed Sepsis Patients

NCT02797431 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-11-29

No results posted yet for this study

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.

Conditions

  • Severe Sepsis With Septic Shock

Interventions

DRUG

Interleukin-7

IM administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR\>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

  • Revimmune

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    collaborator OTHER

  • University Hospital, Limoges

    lead OTHER

Principal Investigators

  • Bruno FRANCOIS, DM · University Hospital, Limoges

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

Countries

  • France

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 NCT02797431 on ClinicalTrials.gov