ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33716
• EU PAS number:
  EUPAS10565
• Study ID:
  33716
• Official title and acronym:
  ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Greece

  Italy
• Study description:
  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 status:
  Finalised

Research institutions and networks

Institutions

Addmedica

Multiple centres: 48 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 11/12/2007

Actual: 11/12/2007

Study start date

Planned: 01/06/2008

Actual: 21/01/2009

Data analysis start date

Planned: 31/01/2019

Actual: 31/01/2019

Date of final study report

Planned: 16/12/2019

Actual: 16/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Addmedica

Study protocol

Initial protocol

Protocol ESCORT-HU _amended final version_20080618

Updated protocol

ESCORT Protocol amendment 2 - 20102017 (EN)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)