European Sickle Cell Disease Cohort - Hydroxyurea

• Status: Completed
• Trial end date: 2019-03-20
• Target enrollment: 0
• Participant gender: All

Summary

In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ADDMEDICA SASA
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

• Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults)

• With symptomatic sickle cell syndrome

• Treated with Siklos®

• Having been informed of the study by the initiating physician and consenting to participate to the cohort.