Studying Complement Inhibition in Complex Cardiac Surgery

NCT02866825 | Completed Phase 2 DMC

• 2 other identifiers: IFX-1-P2.22015-003036-12
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Inflammation; Systemic Inflammatory Response Syndrome; Pathologic Processes; Organ Dysfunction

Outcome Measures

Primary Outcomes (1)

• Peak level of IL-6

  From prior study drug administration until 24h after start of cardiopulmonary bypass (CPB) (CPB)

Secondary Outcomes (13)

• Plasma concentration of IFX-1 at each timepoint measured

  Data will be collected at the following approximate time points: prior study drug administration; 30 min after start of infusion; up to 10 min after cessation of CPB; 3h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15

• Maximum observed concentration (Cmax) of IFX-1

  Data will be collected at the following approximate time points: prior study drug administration; 30 min after start of infusion; up to 10 min after cessation of CPB; 3h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15

• Area under the curve (AUC) of plasma concentration of IFX-1

  Data will be collected at the following approximate time points: prior study drug administration; 30 min after start of infusion; up to 10 min after cessation of CPB; 3h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15

• Plasma concentration of free, detectable C5a at each timepoint measured

  Data will be collected at the following approximate time points: prior study drug administration, prior start of CPB, up to 10 min after cessation of CPB; 3h, 6h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15

• Serum levels of CH50 at each timepoint measured

  Data will be collected at the following approximate time points: prior study drug administration, prior start of CPB, up to 10 min after cessation of CPB; 3h, 6h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15

Study Arms (2)

IFX-1

ACTIVE COMPARATOR

dose escalating single i.v. administration of IFX-1 (verum)

Biological: IFX-1

Placebo

PLACEBO COMPARATOR

dose escalating mimicing single i.v. administration of placebo

Biological: Placebo

Interventions

IFX-1 BIOLOGICAL

IFX-1

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years old
• Written informed consent
• One of the following cardiac surgical procedures is planned with Cardiopulmonary bypass (CPB):
• Single valve surgery in combination with at least two coronary artery bypass grafts (CABGs)
• Multiple valve surgery with or without CABG
• Single or multiple valve surgery in combination with ascending aorta procedure with or without additional CABG
• Re-surgery of aortic valve, mitral valve, aortic arch or ascending aorta with or without CABG
• Cardiac surgery is performed electively

You may not qualify if:

• Weight \> 130 kg
• The following cardiac surgical procedures:
• Cardiac surgical procedure is planned as minimally invasive procedure (e.g., without thoracotomy or with lateral incision, minimal thoracotomy)
• Cardiac surgery with an expected CPB time less than 100 minutes
• Other cardiac and vascular diseases and/or procedures:
• Prior cardiac surgery within the past 6 months
• History of heart transplantation or planned heart transplantation
• Requiring inotropic, vasopressor or mechanical circulatory support
• Requiring ventilatory support
• Other disease or condition that is likely to interfere with the evaluation of the study drug:
• Active infective endocarditis
• Stroke or transient ischemic attack (TIA) within the last 6 months
• Concomitant disease with a life expectancy of less than 6 months
• Cardiopulmonary resuscitation within the last 4 weeks
• Patients requiring renal replacement therapy

Sponsors & Collaborators

• InflaRx GmbH: lead

Study Sites (10)

Study Site

Aachen, Germany

Location

Study Site

Dortmund, Germany

Location

Study Site

Dresden, Germany

Location

Study Site

Freiburg im Breisgau, Germany

Location

Study Site

Heidelberg, Germany

Location

Study Site

Jena, Germany

Location

Study Site

Kiel, Germany

Location

Study Site

Leipzig, Germany

Location

Study Site

Trier, Germany

Location

Study Site

Tübingen, Germany

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Interventions

vilobelimab

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Torsten Doenst, Prof. Dr.

  University Hospital Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: August 15, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)