European Sickle Cell Disease Cohort – Hydroxyurea – Extension study (ESCORT-HU Extension)

Study identification

• EU PAS number:
  EUPAS1000000066
• Study ID:
  1000000066
• Official title and acronym:
  European Sickle Cell Disease Cohort – Hydroxyurea – Extension study (ESCORT-HU Extension)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Greece

  Italy
• Study description:
  As safety information pertaining to the long-term use of hydroxyurea (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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

THERAVIA

Study timelines

Date when funding contract was signed

Actual: 12/08/2020

Study start date

Actual: 12/08/2020

Data analysis start date

Planned: 06/10/2025

Date of final study report

Planned: 01/02/2026

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

SIK-EU-20-1