CompletedPhase 2

Studying Complement Inhibition in Complex Cardiac Surgery

Germany116 participantsStarted 2016-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female patients ≥ 18 years old
✓. Written informed consent
✓. One of the following cardiac surgical procedures is planned with Cardiopulmonary bypass (CPB):
✓. Cardiac surgery is performed electively

Exclusion criteria

✕. Weight \> 130 kg
✕. The following cardiac surgical procedures:
✕. Other cardiac and vascular diseases and/or procedures:
✕. Other disease or condition that is likely to interfere with the evaluation of the study drug:
✕. 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:
✕. Positive test for human immunodeficiency virus (HIV), hepatitis B or C

What they're measuring

Peak level of IL-6

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

Trial details

NCT IDNCT02866825

SponsorInflaRx GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

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