CLINICAL STUDIES

The DEEP project is a European research project that investigates the effects of deferiprone in patients with hereditary haemoglobinopathies, such as thalassaemia. The project is made up of three clinical trials which, once completed, will provide the data needed to make the best use of deferiprone in paediatric patients.

Once the DEEP project has achieved the expected results, young thalassaemia patients will be able to take deferiprone safely and effectively.

During the DEEP clinical studies, children and young people are closely monitored by doctors and researchers. In any case, just as they can choose voluntarily whether or not to participate on the studies, they can also choose to withdraw at any time. Whatever their choice, the doctors will continue to give them the best treatment possible.

The DEEP project is divided into three different studies:

DEEP-1: Study of the pharmacokinetics of deferiprone in children under the age of six
The researchers administer a dose of deferiprone to a group of paediatric patients under the age of 6 in order to study the absorption, distribution, metabolism and elimination of the drug.

DEEP-2: Study to compare the efficacy and safety of deferiprone and deferasirox in paediatric patients
The researchers administer deferiprone and deferasirox to a group of paediatric patients under the age of 18 for one year. At the end of the treatment period for all of the patients, they compare the effect of the two drugs.

DEEP-3: Study of long-term safety of deferiprone in paediatric patients
The researchers collect information on the adverse effects of deferiprone, directly from clinical records or during routine visits, in a group of paediatric patients who began taking the drug before the age of 18. The purpose of the study is to ensure that the drug can be used safely in this patient population for many years.