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Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction

NCT02246595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-04-25

No results posted yet for this study

Summary

The trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. The primary goal of the trial is to assess the pharmacokinetics and pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and tolerability as well as evaluate parameters of efficacy.

Conditions

  • Severe Sepsis
  • Septic Shock

Interventions

BIOLOGICAL

CaCP29

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • InflaRx GmbH

    lead INDUSTRY

Principal Investigators

  • Michael Bauer, Prof. Dr. · University Hospital Jena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Germany

Study Locations

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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 NCT02246595 on ClinicalTrials.gov