At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,906 enrolled
Drug / intervention
Siklosdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea
In Brief
An observational study evaluating Siklos for Sickle Cell Disease. Completed, enrolled 1,906 participants across 60 sites in 7 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesFrance, French Guiana, Germany, Greece, Guadeloupe, Italy, Martinique
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2009
First PostedAug 2015
Primary CompletionMar 2019
TodayJul 2026
First PostedAug 6, 2015
Enrollment StartJan 1, 2009
Primary CompletionMar 20, 2019
TodayJul 2, 2026
Enrollment to primary: 10.2 yearsPosted 10.9 years ago
Interventions
Siklosdrug