A Phase 1b/2a Trial to Evaluate Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care.
Condition(s) studied
Investigational drug(s) / intervention(s)
AK1967 (Invobenitug also known as Procizumab): DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
Placebo: Application of placebo
Study summary
The objective of this Phase 1b/2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as procizumab), a monoclonal antibody under development for the treatment of cardiogenic shock (CS). CS is a life-threatening hypoperfusion of vital organs that frequently results in death. In addition to safety and tolerability, pharmacokinetics and pharmacodynamics of invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.
Eligibility
Primary outcome measure(s)
- Reported number of treatment-emergent adverse events from start of Invobenitug administration up until the last follow-up visit after Invobenitug administration — 30 days
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| Yerevan medical scientific center | Yerevan | Armenia | Not Yet Recruiting |
| Erebouni Mwdical Center | Yerevan | Armenia | Not Yet Recruiting |
| Heart Center Aalst, AZORG | Aalst | Belgium | Recruiting |
| University Hospital Saint Pierre | Brussels | Belgium | Recruiting |
| Ghent University Hospital | Ghent | Belgium | Not Yet Recruiting |
| University Hospital and Medical Faculty of Pilsen | Pilsen | Czechia | Recruiting |
| Charles University Motol University Hospital | Prague | Czechia | Recruiting |
| General University Hospital in Prague - FVN | Prague | Czechia | Recruiting |
| Institute of Clinical and Experimental Medicine - IKEM | Prague | Czechia | Recruiting |
| University Hospital Avicenne AP-HP | Bobigny | France | Recruiting |
| Département d'anesthésie-réanimation | Dijon | France | Not Yet Recruiting |
| University Hospital Lille - Institut Cœur Poumon | Lille | France | Recruiting |
| University Hospital - Dupuytren Limoges | Limoges | France | Recruiting |
| Regional University Hospital Nancy - Hopitaux de Brabois | Nancy | France | Recruiting |
| Hôpital Pitié Salpêtrière | Paris | France | Not Yet Recruiting |
| Lariboisière Hospital AP-HP | Paris | France | Recruiting |
| Deutsches Herzzentrum der Charite (DHZC) | Berlin | Germany | Not Yet Recruiting |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany | Not Yet Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Not Yet Recruiting |
| Herzzentrum Leipzig GmbH | Leipzig | Germany | Not Yet Recruiting |
| Universitätsmedizin Mannheim | Mannheim | Germany | Not Yet Recruiting |
| Radboud University Medical Center | Nijmegen | Netherlands | Recruiting |
| Uniersytecki Szpital Kliniczny w Białystoku | Bialystok | Poland | Recruiting |
| Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach | Katowice | Poland | Recruiting |
| Clinical University Hospital Poznań | Poznan | Poland | Recruiting |
| J. Mikulicz Radecki Clinical University Hospital Wrocław | Wroclaw | Poland | Recruiting |
| Clinical Hospital Center Bezanijska Kosa | Belgrade | Serbia | Not Yet Recruiting |
| Institute for Cardiovascular Diseases of Vojvodina | Kamenitz | Serbia | Not Yet Recruiting |
| Clinical Center Niš | Niš | Serbia | Not Yet Recruiting |
| Fundación Pública Galega de Investigación Biomédica INIBIC | A Coruña | Spain | Not Yet Recruiting |
| Fundació Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not Yet Recruiting |
| Fundació Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not Yet Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Not Yet Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Not Yet Recruiting |
| L'Hospitalet de Llobregat | Barcelona | Spain | Not Yet Recruiting |
| Fundación para la Investigación Biomédica del Hospital Universitario La Paz | Madrid | Spain | Not Yet Recruiting |
| Hospital Universitario 12 De Octubre | Madrid | Spain | Not Yet Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06832722 on ClinicalTrials.gov ↗ ← All trials in Spain