OSequIT – Multicentric Randomized Clinical Trial of Deferasirox-Deferiprone Sequential Therapy versus Deferasirox or Deferiprone

OSequIT – Multicentric Randomized Clinical Trial of Deferasirox-Deferiprone Sequential Therapy versus Deferasirox or Deferiprone 2018-10-02T07:49:57+00:00

Role of CVBF

Partner

Description

The OSequIT project is a multi-centre randomized clinical trial to compare the safety and efficacy of Deferasirox and Deferiprone administrated in sequential mode versus Deferasirox or Deferiprone in monotherapy in patients affected by Thalassemia Major. The project is coordinated by Dr. Angela Vitrano and Prof. Aurelio Maggio of “Franco and Piera Cutino” Foundation in Palermo and is expected to bring the following results:
a) Effectiveness of sequential treatment in comparison with monotherapies, measured as variation of repeated measures of SF (Serum Ferritin) levels;
b) Risk-benefit ratio evaluation of the available chelators when used alone or in combination (effectiveness versus AEs such as hypertransaminasemia, neutropenia, agranulocitosys, arthropathy, nausea) during controlled regimen;
c) Organ specific effectiveness evaluated by MRI even considering the possible synergistic action of the two oral chelators in the hearth or in different organs;
d) Cost-effectiveness analysis and identification of treatments that could results in a money saving by National Health Service (NHS) (less complications, minor costs of the drugs).
In the framework of the project, CVBF will provide support for Ethics approval and Competent Authority authorisation; monitoring activities; clinical study reporting; pharmacovigilance activities.

Funds

EU Contribution

Duration

2 Years

Partners

“Franco and Piera Cutino” Foundation – Italy, Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) – Italy