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Studying Complement Inhibition in Complex Cardiac Surgery

NCT02866825 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2017-02-15

No results posted yet for this study

Summary

The trial enrolls patients undergoing a complex cardiac surgery. The primary goal of the trial is to evaluate the pharmacodynamic dose response relationship of the monoclonal antibody IFX-1 in these patients. In addition, this trial further aims to characterize the safety and the pharmacokinetics of IFX-1 as well as to collect first data on its efficacy on clinical surrogate endpoints.

Conditions

  • Systemic Inflammatory Response Syndrome
  • C.Surgical Procedure; Cardiac

Interventions

BIOLOGICAL

IFX-1

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • InflaRx GmbH

    lead INDUSTRY

Principal Investigators

  • Torsten Doenst, 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
2016-05-31
Primary Completion
2016-12-31
Completion
2017-01-31

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 NCT02866825 on ClinicalTrials.gov