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Systemic Inflammatory Response SyndromePhase 2CARDIACNCT02866825

Studying Complement Inhibition in Complex Cardiac Surgery

A Phase 2 study testing IFX-1 in people with Systemic Inflammatory Response Syndrome and C.Surgical Procedure; Cardiac, run by InflaRx GmbH at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IFX-1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
10 sitesGermany
Study dates
May 2016to Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 46Show fewer
  • 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
  • Cerebrovascular disease requiring concomitant carotid endarterectomy
  • Active infection with or without a temperature greater than 38°C
  • 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)
  • Positive test for human immunodeficiency virus (HIV), hepatitis B or C
  • 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
  • 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
  • Planned corticosteroid pulse therapy to prevent SIRS
  • Patients with known hypersensitivity to any constituent of the investigational medicinal product (IMP)
  • 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)

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Study Site

    Aachen

  • Study Site

    Dortmund

  • Study Site

    Dresden

  • Study Site

    Freiburg im Breisgau

  • Study Site

    Heidelberg

  • Study Site

    Jena

  • Study Site

    Kiel

  • Study Site

    Leipzig

  • Study Site

    Trier

  • Study Site

    Tübingen

Other trials in Germany

About this study

Official title: 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

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.

Being tested
IFX-1, Placebo
Keywords
Inflammation, Systemic Inflammatory Response Syndrome, Pathologic Processes, Organ Dysfunction
Medical subject headings
Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IFX-1Biological

  • PlaceboBiological

Study groups in NCT02866825
Study groupRoleWhat they receive
IFX-1Active comparatordose escalating single i.v. administration of IFX-1 (verum)
Receives: Biological: IFX-1
PlaceboPlacebo comparatordose escalating mimicing single i.v. administration of placebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak level of IL-6

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

Secondary outcomes (13)

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

    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

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

    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

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

    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

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

    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

  5. Serum levels of CH50 at each timepoint measured

    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

  6. Serum levels of IL-6 compared to baseline

    Measured: 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

    Measured: 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

    Measured: From screening visit until Day 29

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

    Measured: Up to Day 15

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

    Measured: 24h after end of surgery

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

    Measured: 48h after end of surgery

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

    Measured: 24h after end of surgery

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

    Measured: 24h, 48h and 96h after start of CPB

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866825
Sponsor's protocol ID
IFX-1-P2.2
Other IDs
2015-003036-12, 2015
Acronym
CARDIAC
Status last verified
Feb 2017
First submitted
17 Jun 2016
Last updated
15 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IFX-1 in people with Systemic Inflammatory Response Syndrome and C.Surgical Procedure; Cardiac, run by InflaRx GmbH at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak level of IL-6 (time frame: From prior study drug administration until 24h after start of cardiopulmonary bypass (CPB) (CPB)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.

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CARDIAC Clinical Trial NCT02866825 | AzTrials