ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension
ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension
As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.
Inclusion Criteria:
To allow risk evaluation, participants must belong at least to one of the subpopulations defined below:
Participants previously enrolled in ESCORT-HU who agree to participate in ESCORT-HU Extension study,
New participants with any of the following criteria:
Saint-Laurent-du-Maroni, 97393, French Guiana
Saint-Laurent-du-Maroni, 97393, French Guiana