Safety and effect of Itolizumab in extracorporeal circulation, phase I/II

SAFETY AND EFFECT OF ITOLIZUMAB ON THE INFLAMMATORY RESPONSE IN PATIENTS WITH VALVULAR OR CORONARY HEART DISEASE WHO ARE GOING TO UNDERGO CARDIAC SURGERY WITH EXTRACORPOREAL CIRCULATION - ITOCEC STUDY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000449

Enrollment

Registered

2024-08-22

Start date

2024-09-30

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular or coronary disease with cardiac surgery and use of extracorporeal circulation

Interventions

Cardiac surgery with extracorporeal circulation and itolizumab group (Experimental): Administration of Itolizumab at a dose of 1.6 mg/kg, duration 2-4 hours, by intravenous infusion, is added before t

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with a diagnosis of valvular disease (mitral or aortic) or coronary artery who are going to undergo cardiac surgery with extracorporeal circulation. 2. Patients who have consented to participate in the research.

Exclusion criteria

Exclusion criteria: 1. Pregnant women, breastfeeding women or women of childbearing age without effective contraceptive methods. 2. Psychiatric or cognitive disorders that do not allow understanding of the study. 3. Systemic inflammatory disease. 4. Autoimmune disease. 5. Oncological disease. 6. Contraindications related to surgical operations in general such as general anesthesia. 7. Be receiving any immunosuppressive treatment. 8. Be receiving another product under investigation. 9. Indication for reintervention of cardiac surgery. 10. Require an emergency cardiac procedure.

Design outcomes

Primary

Measure	Time frame
1. Serious adverse events with proven causal relationship: definite, very probable or probable (Yes, No). Measurement time: preoperative check-up (baseline value), before surgery, day 1, day 2 and day 3 post surgery, every 72 h after day 3 (during the time of stay in the Intensive Care Unit (ICU)), at discharge from the ICU and, at any time until day 30 post surgery in case of symptoms or clinical signs that indicate the presence of an adverse event. 2. Circulating concentration of IL-6 in blood (pg/mL). Measurement time: preoperative check-up (baseline value), before surgery, 4 h after the end of the surgical procedure, day 1 post surgery, day 2 post surgery, day 3 post surgery, every 72 h after day 3 (during the time of stay in the ICU) and, upon discharge from the ICU.	—

Measure

Time frame

1. Serious adverse events with proven causal relationship: definite, very probable or probable (Yes, No). Measurement time: preoperative check-up (baseline value), before surgery, day 1, day 2 and day 3 post surgery, every 72 h after day 3 (during the time of stay in the Intensive Care Unit (ICU)), at discharge from the ICU and, at any time until day 30 post surgery in case of symptoms or clinical signs that indicate the presence of an adverse event. 2. Circulating concentration of IL-6 in blood (pg/mL). Measurement time: preoperative check-up (baseline value), before surgery, 4 h after the end of the surgical procedure, day 1 post surgery, day 2 post surgery, day 3 post surgery, every 72 h after day 3 (during the time of stay in the ICU) and, upon discharge from the ICU.

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Secondary

Measure	Time frame
1. Adverse Events-AE (Occurrence of AE (Yes, No); Type of AE (To be classified and grouped by organ class and system using CTCAE v5.0 terminology); Intensity of AE (Mild, Moderate, Severe, life-threatening or incapacitating, resulting in death); Severity of AE (serious, non-serious); Duration of AE (Time elapsed between onset and termination dates of AE); Causal relationship of AE (definite, very likely, probable, possible, unrelated, unknown); Management of AE onset (no change in dose, temporary discontinuation, permanent discontinuation of study treatment); Outcome of AE (recovered/resolved, improving/resolving, persistent/unresolved, with sequelae requiring treatment, with sequelae not requiring treatment, fatal, unknown)). Measurement time: preoperative check-up (baseline), prior to surgery, day 1, day 2, and day 3 post-surgery, every 72 h after day 3 (during the time of stay in the ICU), upon discharge from the ICU, at any time up to day 30 post-surgery in case of symptoms or clinical signs indicating the presence of an adverse event. 2. Circulating blood concentration of IL-8 (pg/mL). Time of measurement: preoperative check-up (baseline value), 4 h after the end of the surgical procedure, day 1 post-surgery, day 2 post-surgery, day 3 post-surgery, at discharge from the ICU. 3. Circulating blood concentration of IL-1 (pg/mL). Time of measurement: preoperative check-up (baseline value), 4 h after the end of the surgical procedure, day 1 post-surgery, day 2 post-surgery, day 3 post-surgery, at discharge from the ICU. 4. Circulating blood concentration of IFN-gamma (pg/mL). Time of measurement: preoperative check-up (baseline value), 4 h after the end of the surgical procedure, day 1 post-surgery, day 2 post-surgery, day 3 post-surgery, at discharge from the ICU. 5. Circulating blood concentration of IL-10 (pg/mL). Measurement time: preoperative check-up (baseline), 4 h after the end of the surgical procedure, day 1 post-surgery, day 2 post-surgery, day 3 post-sur	—

Measure

Time frame

1. Adverse Events-AE (Occurrence of AE (Yes, No); Type of AE (To be classified and grouped by organ class and system using CTCAE v5.0 terminology); Intensity of AE (Mild, Moderate, Severe, life-threatening or incapacitating, resulting in death); Severity of AE (serious, non-serious); Duration of AE (Time elapsed between onset and termination dates of AE); Causal relationship of AE (definite, very likely, probable, possible, unrelated, unknown); Management of AE onset (no change in dose, temporary discontinuation, permanent discontinuation of study treatment); Outcome of AE (recovered/resolved, improving/resolving, persistent/unresolved, with sequelae requiring treatment, with sequelae not requiring treatment, fatal, unknown)). Measurement time: preoperative check-up (baseline), prior to surgery, day 1, day 2, and day 3 post-surgery, every 72 h after day 3 (during the time of stay in the ICU), upon discharge from the ICU, at any time up to day 30 post-surgery in case of symptoms or clinical signs indicating the presence of an adverse event. 2. Circulating blood concentration of IL-8 (pg/mL). Time of measurement: preoperative check-up (baseline value), 4 h after the end of the surgical procedure, day 1 post-surgery, day 2 post-surgery, day 3 post-surgery, at discharge from the ICU. 3. Circulating blood concentration of IL-1 (pg/mL). Time of measurement: preoperative check-up (baseline value), 4 h after the end of the surgical procedure, day 1 post-surgery, day 2 post-surgery, day 3 post-surgery, at discharge from the ICU. 4. Circulating blood concentration of IFN-gamma (pg/mL). Time of measurement: preoperative check-up (baseline value), 4 h after the end of the surgical procedure, day 1 post-surgery, day 2 post-surgery, day 3 post-surgery, at discharge from the ICU. 5. Circulating blood concentration of IL-10 (pg/mL). Measurement time: preoperative check-up (baseline), 4 h after the end of the surgical procedure, day 1 post-surgery, day 2 post-surgery, day 3 post-sur

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Countries

Cuba

Contacts

Public ContactYanelda Garcia Vega

Center of Molecular Immunology (CIM)

yaneldag@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026