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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ITOCEC STUDY

Scientific title:

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

Acronym of Scientific Title:

ITOCEC STUDY

Secondary indentifying numbers:

C31 PCL-0004

Issuing authority of the secondary identifying numbers:

Center for Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center for Molecular Immunology (CIM)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Anselmo

Midle name:

Antonio

Last name:

Abdo Cuza

Medical Specialty :

Second Degree Specialist in Intensive and Emergency Medicine

Affiliation:

Medical Surgical Research Center (CIMEQ)

Postal address:

Calle 216 and 11b, Siboney, Playa

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-52091442

Email address:

aaabdo@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Medical Surgical Research Center (CIMEQ), Miguel Angel Blanco Gonzalez, First degree Specialist in Cardiology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

30/09/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

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

Intervention(s):

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 the surgical procedure Cardiac surgery with extracorporeal circulation group (Control): Only the surgical procedure will be carried out

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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-surgery, discharge from the ICU. 6. Circulating blood concentration of IL-18 (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-surgery, discharge from the ICU. 7. Circulating blood concentration of TNF-alpha (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-surgery, discharge from the ICU. 8. LDH concentration (U/L). Measurement time: preoperative check-up (baseline), prior to 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 ICU stay), upon discharge from the ICU. 9. C-reactive protein concentration (pg/L). Measurement time: preoperative check-up (baseline), prior to 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 ICU stay), upon discharge from the ICU. 10. Respiratory function (normal, dysfunction, organ failure). Measurement time: preoperative check-up (baseline value), day 1 post surgery, day 2 post surgery, day 3 post surgery, every 72 h after day 3 (during the time of stay in ICU), upon discharge from ICU. 11. Hematological function (normal, dysfunction, organ failure). Measurement time: preoperative check-up (baseline value), day 1 post surgery, day 2 post surgery, day 3 post surgery, every 72 h after day 3 (during the time of stay in ICU), upon discharge from ICU. 12. Cardiovascular, renal and hepatic function (normal, dysfunction, organ failure). Measurement time: preoperative check-up (baseline value), day 1 post surgery, day 2 post surgery, day 3 post surgery, every 72 h after day 3 (during the time of stay in ICU), upon discharge from ICU. 13. Renal function (normal, dysfunction, organ failure). Measurement time: preoperative check (baseline value), day 1 post surgery, day 2 post surgery, day 3 post surgery, every 72 h after day 3 (during ICU stay), at ICU discharge. 14. Liver function (normal, dysfunction, organ failure). Measurement time: preoperative check (baseline value), day 1 post surgery, day 2 post surgery, day 3 post surgery, every 72 h after day 3 (during ICU stay), at ICU discharge. 15. Use of vasopressors (Yes, No). Measurement time: daily until discharge from ICU or final evaluation of the study (30 days post surgery). 16. Need for mechanical ventilation (Yes, No). Measurement time: daily until discharge from ICU or final evaluation of the study (30 days post surgery). 17. Type of mechanical ventilation (noninvasive, invasive). Measurement time: daily until discharge from ICU or final evaluation of the study (30 days post surgery). 18. Duration of mechanical ventilation (Time elapsed from the start to the end of mechanical ventilation. Time of measurement: daily until discharge from the ICU or final evaluation of the study (30 days post surgery). 19. ICU stay (number of days measured from arrival in the ICU to the date of discharge from the ICU). Time of measurement: daily up to 30 days. 20. Hospital stay (number of days measured from arrival in the ICU to the date of discharge from hospital). Time of measurement: daily up to 30 days. 21. Mortality at 30 days (death, not death). Time of measurement: for 30 days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

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:

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

1-2

Target sample size:

38

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yanelda

Middle Name:

de los Angeles

Last Name:

Garcia Vega

Specialty:

Lic. in Biochemistry, M. Sc. in the Clinical Laboratory

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 15 esq. 216, Siboney, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72717933, ext 3397

Email :

yaneldag@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Anselmo

Middle Name:

Antonio

Last Name:

Abdo Cuza

Specialty:

Second Degree Specialist in Intensive and Emergency Medicine

Affiliation:

Medical Surgical Research Center (CIMEQ)

Postal Address:

Calle 216 and 11b, Siboney, Playa

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-52091442

Email :

aaabdo@infomed.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Medical Surgical Research Center (CIMEQ)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

20/04/2023

Postal address of Ethic Committee :

Calle 216 y 11 B, Siboney. Playa. Havana, ZC: 10400. Cuba

Telephone:

+53-72726643

Email:

karelduran.mtz @infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

31/05/2025

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000449

Date of Registration in Primary Registry:

22/08/2024

Record Verification Date:

2024/08/22

Next update date:

2025/08/22

Link to the spanish version:

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

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