Safety registry for Eurartesim

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28484
• EU PAS number:
  EUPAS6942
• Study ID:
  28484
• Official title and acronym:
  Safety registry for Eurartesim
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  A multi-centre safety registry for malaria patients treated with Eurartesim which aims to study the association between safety parameters (particularly QTc prolongation) and various factors including age, gender, ethnicity, lifestyle factors, food intake and co-morbidities/co-medications. Any patient with malaria who is treated with Eurartesim is eligible to participate. The registry aims to enrol 300 patients in 7 countries.
• Study status:
  Finalised

Research institutions and networks

Institutions

ICON Commercialisation & Outcomes

Germany

Ireland

Multiple centres: 19 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/11/2014

Actual: 01/11/2014

Study start date

Planned: 01/07/2012

Actual: 13/05/2013

Date of interim report, if expected

Planned: 03/07/2013

Actual: 03/07/2014

Date of final study report

Planned: 31/10/2017

Actual: 04/07/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sigma-Tau

Study protocol

Initial protocol

3381_Eurartesim Safety Registry_Protocol_20120611_v6.0_Clean

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)