ERMES (Non-PASS)

• Research type

  Research Study

• Full title

  ERMES - European Real world observational study on Management strategies with Eltrombopag in ITP to detect outcome predictive factorS

• IRAS ID

  295705

• Contact name

  Sharon Supekar

• Contact email

  sharon.supekar@novartis.com

• Sponsor organisation

  Novartis Farma SpA

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Summary of Research
  Eltrombopag has been shown to be effective and safe in controlled clinical trials. This study mainly is to better describe how eltrombopag is used in the real life setting and to record the effectiveness and the safety in the routine clinical practice. The study also aims to describe how eltrombopag impacts on people’s quality of life.
  A NIS is a study in which individuals are only observed during their normal treatment with the drug and information on this is collected to continue understanding how the drug works in an everyday real-life setting. The treatment decisions made by study doctor, including any medications he/she may prescribe. Information collected in this study will continue to help understand how the drug is used and works in different patients in several countries.

  Summary of Results
  Study has been early terminated in March 2022. As you are aware, the past couple of years have been extremely challenging and our ERMES study has been impacted. We continue to encounter severe delays in site activation and recruitment which are mostly due to the COVID-19 pandemic but also to the changing clinical landscape where the pool of eligible patients is further reduced as more countries in Europe are now prescribing Eltrombopag in a manner which is not compatible with our inclusion-exclusion criteria.
  Despite various efforts, we have only enrolled 76 out of 200 patients over the past 12 months. Therefore, it was assessed that this trial will not be able to reach, within the study timelines, the target number of patients required to meet the study objectives and report meaningful results. We will consequently proceed with early termination of the ERMES study.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  21/LO/0196

• Date of REC Opinion

  6 Jul 2021

• REC opinion

  Further Information Favourable Opinion