European Sickle Cell Disease Cohort - Hydroxyurea (ESCORT-HU)

addmedica

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Drug: Siklos

Study type: Observational

Funder types: Industry

Identifiers

NCT02516579

ESCORT-HU

Details and patient eligibility

About

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.

Enrollment: 1,906 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design