NCT04707235

ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study

ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,093 (actual)
• Sponsor: Theravia · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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®.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Hydroxycarbamide	Patients, aged ≥ 2 years old, with symptomatic SCD, treated with Siklos®.

Timeline

• Start date: 2020-08-21
• Primary completion: 2025-08-21
• Completion: 2025-08-21
• First posted: 2021-01-13
• Last updated: 2024-08-27

Locations

87 sites across 8 countries: France, French Guiana, Germany, Greece, Guadeloupe, Italy, Martinique, Reunion

Regulatory

• FDA-regulated drug study