BIOHOPE recently received the approval of the TRANSBIO clinical study protocol and informed consents forms from the 8 Ethics Committees of the centres involved in the study.
The study will be developed in collaboration with the University Hospital, Hospital del Mar and Hospital Vall’d Hebron (Barcelona, Spain); the Hospital Puerta de Hierro and Hospital La Paz (Madrid, Spain); the RigsHospitalet (Copenhague, Denmark); the Universitätsklinikum Essen (Germany); the University Hospital Borowska (Wroclaw, Poland) and the Massachusetts General Hospital (Boston, USA).
The TRANSBIO clinical study will include 200 patients from these 8 international hospitals, and data on patients’ clinical and immunological history will be collected as well as a blood sample to be tested at IMMUNOBIOGRAM®, which will evaluate the expected response of the patient to the most common immunosuppressive drugs (tacrolimus, cyclosporine, azathioprine, mycophenolic acid, prednisone, sirolimus and everolimus).
The main objective of the clinical study is to confirm the potential clinical utility observed in the preliminary clinical study BH-PILOT whit the participation of 70 patients. This pilot study shown promising results of IIMMUNOBIOGRAM® as an in vitro test to adjust immunosuppressive therapy in a personalized way in patients with kidney transplantation.
Immunosuppressive treatment is essential to prevent rejection of the transplanted organ and the transplanted patients will have to take a combination of medications during all their life. This medication increases the risk of serious health problems and the personalization of the medication could allow each patient to receive those medicines that were potentially more effective, avoiding adverse effects.
The first site initiation visit will be carry out on the 11th May 2018 in the Puerta de Hierro Hospital. The subsequent site initiation visits are also scheduled on May so the recruitment process will be initiated in the next days.
Preliminary results are expected to be available by 1Q2019.