• Join Today!

Become a member and connect with:

  • An Active Online Community
  • Articles and Advice on SCD
  • Help Understanding Clinical Trials
learn more
abstracts & posters

Comparison of the Safety Profile of Sickle Cell Disease Patients Treated with Hydroxycarbamide in Off-Label Versus in-Label Prescriptions in the Escort-HU Non Interventional, Prospective, Observational Open-Label Cohort Study

key information

source: American Society of Hematology

year: 2016

authors: Ersi Voskaridou, Stephan Lobitz, Uwe Kordes, Regine Grosse, Valentine Brousse, Malika Benkerrou, Mariane De Montalembert, Jean-Antoine Ribeil, Frederic Galacteros

summary/abstract:

ESCORT-HU (European Sickle Cell Disease (SCD) COhoRT – HydroxyUrea) is a multicenter prospective non interventional study implemented in Europe, following the European Medical Agency’s request to collect more information focused on long-term safety profile of hydroxycarbamide (HU) in SCD patients treated with HU. Primary endpoint of the study is to determine the frequency of adverse events (AEs) under HU treatment Secondary endpoints include the efficacy of HU in labeled indications (prevention of vaso-occlusive complications and of acute thoracic syndrome), frequency of hospitalizations due to SCD events and frequency of blood transfusions. Data collection on the reason for HU initiation permitted to identify in-label (in the therapeutic indication of the European marketing authorization, group 1, G1) and off-label (other therapeutic indication, group 2, G2) prescriptions of HU. Frequency of AEs (including not related to SCD and infections) was compared between adults and children, both in G1 and G2, with focus on the following subclasses: blood and lymphatic system disorders, fever, gastrointestinal disorders, infection, nervous system disorders, skin and subcutaneous tissue disorders and others.

organization: Laiko General Hospital, Athens; Charité-Universitätsmedizin, Berlin; Universitätsklinikum Hamburg-Eppendorf; University Medical Center Hamburg-Eppendorf; Hôpital Universitaire Necker-Enfants Malades, Paris; Laboratory of Excellence, GR-ex, Paris; Hopital Robert Debré, APHP, Paris; Centre de la Drépanocytose, Hôpital Henri Mondor, Creteil

read more

expertly curated content related to this topic

Don’t forget to join the oneSCDvoice community!

To improve your experience on this site, we use cookies. This includes cookies essential for the basic functioning of our website, cookies for analytics purposes, and cookies enabling us to personalize site content. By clicking on 'Accept' or any content on this site, you agree that cookies can be placed. You may adjust your browser's cookie settings to suit your preferences. More information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close