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Immunomodulation of EA-230 Following On-pump Coronary Artery Bypass Grafting (CABG)

NCT03145220 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-06-26

No results posted yet for this study

Summary

EA-230 is a newly developed synthetic compound with anti-inflammatory properties, it is a linear tetrapeptide derived from the human chorionic gonadotropin hormone (hCG). Recently, its immunomodulatory effects in humans were confirmed in a phase I trial and an optimal dose was established. To establish this anti-inflammatory effect in a selected patient population and assess clinical outcome, a combined phase IIa/IIb trial will be conducted with patients undergoing cardiac surgery.

Conditions

  • Systemic Inflammatory Response Syndrome
  • Coronary Artery Bypass Grafting

Interventions

DRUG

EA-230

Active intervention

OTHER

Placebo (NaCl)

Placebo intervention

Sponsors & Collaborators

  • Exponential Biotherapies Inc.

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Netherlands

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 NCT03145220 on ClinicalTrials.gov