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Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock

NCT04055909 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2023-04-11

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.

Conditions

  • Shock, Septic

Interventions

DRUG

nangibotide low dose

nangibotide 0.3 mg/kg/h

DRUG

nangibotide high dose

nangibotide 1.0 mg/kg/h

DRUG

placebo

matching placebo

Sponsors & Collaborators

  • Inotrem

    lead INDUSTRY

Principal Investigators

  • Jean-Jacques Garaud, MD · CEO and Medical Officer

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
2019-11-13
Primary Completion
2022-05-09
Completion
2023-05-09
FDA Drug
Yes

Countries

  • Belgium
  • Denmark
  • Finland
  • France
  • Ireland
  • Spain

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 NCT04055909 on ClinicalTrials.gov