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Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts in Sepsis Patients

NCT03821038 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-10-27

No results posted yet for this study

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.

Conditions

  • Sepsis, Severe

Interventions

BIOLOGICAL

CYT107

IV twice a week at 10µg/kg for 3 weeks

DRUG

Placebos

IV twice a week at the same volume for 3 weeks

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • University Hospital, Limoges

    collaborator OTHER

  • Emerald Clinical Inc.

    collaborator INDUSTRY

  • Revimmune

    lead INDUSTRY

Principal Investigators

  • Richard Hotchkiss, MD · Washington University School of Medicine

  • Bruno François, MD · Limoges Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-10-06
Completion
2021-10-06
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

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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 NCT03821038 on ClinicalTrials.gov