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CompletedNCT02866825CARDIACUpdated Feb 15, 2017

Studying Complement Inhibition in Complex Cardiac Surgery

A Phase 2 interventional study of IFX-1 and Placebo in Systemic Inflammatory Response Syndrome and C.Surgical Procedure; Cardiac, sponsored by InflaRx GmbH. Completed at 10 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-15.

Sponsored by InflaRx GmbH · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

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

Keywords

  • Inflammation
  • Systemic Inflammatory Response Syndrome
  • Pathologic Processes
  • Organ Dysfunction
03

In context

Systemic Inflammatory Response Syndrome

180 studies on the registry are indexed under Systemic Inflammatory Response Syndrome; 24 are open to participants now.

This study's enrollment of 116 is above the median of 80 across 88 interventional studies indexed under Systemic Inflammatory Response Syndrome.

Browse Systemic Inflammatory Response Syndrome studies →

Lead sponsor

InflaRx GmbH is the lead sponsor of 12 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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):

    • 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
  4. Cardiac surgery is performed electively

Exclusion criteria

Exclusion Criteria:

  1. Weight > 130 kg

  2. 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

  3. 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

  4. 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
  5. Cerebrovascular disease requiring concomitant carotid endarterectomy
  6. Active infection with or without a temperature greater than 38°C

  7. Presence of systemic inflammatory response syndrome defined as occurrence of at least 2 out of the following 4 criteria:

    • Fever > 38.0°C or hypothermia \< 36.0°C
    • Tachycardia > 90 beats/minute
    • Tachypnea > 20 breaths/minute
    • Leucocytosis > 12 x 109/l or leucopenia \< 4 x 109/l or > 10% immature neutrophils (bands)
  8. Positive test for human immunodeficiency virus (HIV), hepatitis B or C

  9. One of the following abnormal laboratory results:

    • Hemoglobin \< 5 mmol/l (\< 8.06 g/dl)
    • Total bilirubin ≥ 2 x upper normal limit (UNL)
    • CRP > 3 x UNL
    • ALAT > 3 x UNL
    • ASAT > 3 x UNL
    • White blood cell count \< 2,500/mm³
    • White blood cell count > 12,000/mm³

  10. Prohibited concomitant medications:

    • Immunomodulatory drugs within past 30 days (e.g., TNF-inhibitors)
    • Immunosuppressive drugs within past 30 days (e.g., cyclosporine, tacrolimus)
    • High dose corticosteroids (e.g., > 50 mg prednisone/day or equivalent) within past 14 days
    • Any systemic anticancer treatment within the past 3 months
  11. Planned corticosteroid pulse therapy to prevent SIRS
  12. Patients with known hypersensitivity to any constituent of the investigational medicinal product (IMP)

  13. General exclusion criteria:

    • Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
    • Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
    • Participation in any interventional clinical trial within the last three months
    • Prior randomization in this clinical trial (screen failures can be re-screened, if appropriate)
    • Alcohol, drug, or medication abuse
    • Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
    • No commitment to full aggressive life support (e.g., DNR order)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
116 participants (actual)

Study arms

  • Active comparator
    IFX-1

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

    Biological: IFX-1

  • Placebo comparator
    Placebo

    dose escalating mimicing single i.v. administration of placebo

    Biological: Placebo

Interventions

  • BiologicalIFX-1
  • BiologicalPlacebo
06

What researchers measure

Primary outcomes

  1. Peak level of IL-6

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

Secondary outcomes

  1. Plasma concentration of IFX-1 at each timepoint measured

    Time frame: 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

  2. Maximum observed concentration (Cmax) of IFX-1

    Time frame: 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

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

    Time frame: 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

  4. Plasma concentration of free, detectable C5a at each timepoint measured

    Time frame: 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

  5. Serum levels of CH50 at each timepoint measured

    Time frame: 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

  6. Serum levels of IL-6 compared to baseline

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

  7. Serum levels of IL-8 compared to baseline

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

  8. Incidence of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) until Day 29

    Time frame: From screening visit until Day 29

  9. Number of patients with detection of anti-drug-antibodies

    Time frame: Up to Day 15

  10. Number of patients that are successfully extubated 24h after end of surgery

    Time frame: 24h after end of surgery

  11. Number of patients with consecutive invasive ventilation for more than 48h after end of surgery

    Time frame: 48h after end of surgery

  12. Number of patients that are weaned of any vasopressor use 24h after end of surgery

    Time frame: 24h after end of surgery

  13. Number of patients with SIRS 24h, 48h and 96h after start of CPB

    Time frame: 24h, 48h and 96h after start of CPB

07

Study locations

10 sites
  • Study Site
    Aachen, Germany
  • Study Site
    Dortmund, Germany
  • Study Site
    Dresden, Germany
  • Study Site
    Freiburg, Germany
  • Study Site
    Heidelberg, Germany
  • Study Site
    Jena, Germany
  • Study Site
    Kiel, Germany
  • Study Site
    Leipzig, Germany
  • Study Site
    Trier, Germany
  • Study Site
    Tuebingen, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02866825
Lead sponsor
InflaRx GmbH
Responsible party
Sponsor
First posted
Aug 15, 2016
Start date
May 2016
Primary completion
Dec 2016
Completion
Jan 2017
Last update
Feb 15, 2017

Study contacts

Torsten Doenst, Prof. Dr.
principal investigator · University Hospital Jena

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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