Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The objective of this Phase 1b trial is to evaluate the safety and tolerability of 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 procizumab are evaluated to define the optimum phase 2 dose (P2D) of procizumab.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Signed informed consent.
Diagnosis of CS based on the following entry criteria:
Etiology of CS must be one of the following: ACS, septic or adHF origin
Exclusion Criteria:
Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP.
Patients being longer than 24 hours in the ICU at the time of randomization.
Patients below the age of 18 or above 80 years.
Patients receiving Ang II and/or levosimendan.
Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication.
Stroke or transient ischemic attack within the last 3 months.
SCAI Shock Stage E.
Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset).
Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death.
Only for Part 1: Patients on cannula-based MCS (including VV and VA-ECMO, impella or left ventricular assist device of any type (excluding IABP)) or on renal replacement therapy. Patients who are treated by impella and/or ECMO but have no evidence of hemolysis during screening can be enrolled in the trial.
Patients exceeding a maximum body weight of 120 kg.
CPR lasting more than 15 minutes and/or the patient is not conscious at randomization.
Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease.
Pericardial constriction
Sustained SBP > 120 mmHg during the hour prior to randomization.
Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score >30), known severe chronic pulmonary disease (including COPD classification GOLD4 and/or chronic oxygen therapy and/or restrictive chronic pulmonary disease and/or severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR < 20 ml/min/1.73 m2 or chronic dialysis.
Patients with untreated sepsis.
Patients with valvular heart diseases as the primary cause of cardiogenic shock.
Other known causes of shock, namely
Patients who have severe immune suppression such as recent (<3 months) chemotherapy and/or severe neutropenia (neutrophil count <500 cells/mm3) and/or chronic high glucocorticoid dose (≥0.5 mg/kg per day of prednisone equivalent) and/or recent (<3 months) organ transplantation
Patients who have undergone any form of surgery in the last 7 days, except 1) minor surgeries such as cosmetic surgeries, skin surgery, dental surgery and impella implantation 2) surgery for peritonitis with adequate source control, which are allowed.
Women who are pregnant or breastfeeding.
Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization
Primary purpose
Allocation
Interventional model
Masking
130 participants in 3 patient groups, including a placebo group
Loading...
Central trial contact
Gad Cotter, MD; Karakas Mahir, Prof. Dr. Dr.
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal