THYTREG for Cardiac transplant rejection

Inclusion criteria

• {"criterion_text":"- Patient under two years of age, who meets all the requirements necessary to undergo a heart transplant.\n- Patients without contraindication to immunosuppressive drugs.\n- Parents and / or guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document."}

Exclusion criteria

• {"criterion_text":"- Patients with DiGeorge Syndrome, since their thymic function is affected. 2) HIV positive\n- HIV positive serology.\n- Active infection by EBV\n- Patients hyperimmunized with cytotoxic anti-HLA antibodies\n- Patients with a history of prior malignancy\n- Patients who have received induction therapy with Basiliximab or Thymoglobulin\n- Patients who have been previously timectomized or transplanted.\n- Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)\n- Patiens who have to receive a heart in asystolia"}

Primary endpoints

• {"endpoint_text":"- Repopulation of Treg cells in the patient, determined as the increase of their blood values and the recovery of the ratio Treg / T-effector cells with respect to the values prior to transplantation","definition_or_measurement_approach":"Determined as the increase in blood values of Treg cells and recovery of the Treg/T-effector cell ratio relative to pre-transplant values."}

Secondary endpoints

• {"endpoint_text":"- Incidence of episodes of acute myocardial rejection (diagnosed by echocardiography and / or biopsy) that requires treatment in the 2 years post-transplant","definition_or_measurement_approach":"Measured as incidence of clinically significant acute myocardial rejection diagnosed by echocardiography and/or biopsy requiring treatment within 2 years post-transplant."}
• {"endpoint_text":"- Restoration of immunological homeostasis in terms of values of immune populations. The percentages and absolute values of T, B, NK and Treg lymphoid populations and of monocytes, dendritic cells and granulocytes during the post-transplant follow-up period (+7, +14, +21, +30, +60, +90, +120, +150, +180, +270, +365, +545, +730 days)","definition_or_measurement_approach":"Measured by percentages and absolute counts of immune cell populations (T, B, NK, Treg, monocytes, dendritic cells, granulocytes) at specified post-transplant timepoints (+7, +14, +21, +30, +60, +90, +120, +150, +180, +270, +365, +545, +730 days)."}
• {"endpoint_text":"- Survival of the patient","definition_or_measurement_approach":"Measured as patient survival over the follow-up period."}
• {"endpoint_text":"- Security (according to criteria NCI-CTCAE V4.03)","definition_or_measurement_approach":"Safety evaluated according to NCI-CTCAE v4.03 criteria."}

Spain

Earliest CTIS Part Ii Submission Date

26-01-2025

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

4

Number Of Sites

1

Number Of Participants

11

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Sponsor- Rafael Correa","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Instituto de Salud Carlos III","duties_or_roles":"Source of monetary support","organisation_type":""}