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Clinical Trials/EUCTR2015-003036-12-DE
EUCTR2015-003036-12-DE
Active, not recruiting
Phase 1

A phase II randomized, placebo-controlled, double-blind, dose-escalation study to evaluate safety, pharmacokinetics and pharmacodynamic dose response relationship of IFX-1 in patients undergoing complex cardiac surgery (CARDIAC) - CARDIAC

InflaRx GmbH0 sitesOctober 16, 2015
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ConditionsPrevention of organ dysfunction induced by inflammatory response after complex cardiac surgeryMedDRA version: 20.0Level: PTClassification code 10063101Term: Post procedural inflammationSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 20.0Level: LLTClassification code 10062357Term: SIRSSystem Organ Class: 100000004867Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prevention of organ dysfunction induced by inflammatory response after complex cardiac surgery
Sponsor
InflaRx GmbH
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 16, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Male or female patients \= 18 years old
  • •2\.Written informed consent
  • •3\.One of the following cardiac surgical procedures is planned with Cardiopulmonary bypass (CPB):
  • •a.Single valve surgery in combination with at least two coronary artery bypass grafts (CABGs)
  • •b.Multiple valve surgery with or without CABG
  • •c.Single or multiple valve surgery in combination with ascending aorta procedure with or without additional CABG
  • •d.Re\-surgery of aortic valve, mitral valve, aortic arch or ascending aorta with or without CABG
  • •4\.Cardiac surgery is performed electively
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •1\.Weight \> 130 kg
  • •2\.The following cardiac surgical procedures:
  • •a.Cardiac surgical procedure is planned as minimally invasive procedure (e.g., without thoracotomy or with lateral incision, minimal thoracotomy)
  • •b.Cardiac surgery with an expected CPB time less than 100 minutes
  • •3\.Other cardiac and vascular diseases and/or procedures:
  • •a.Prior cardiac surgery within the past 6 months
  • •b.History of heart transplantation or planned heart transplantation
  • •c.Requiring inotropic, vasopressor or mechanical circulatory support
  • •d.Requiring ventilatory support
  • •4\.Other disease or condition that is likely to interfere with the evaluation of the study drug:

Outcomes

Primary Outcomes

Not specified

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