Cidofovir Exposure Registry Study (CERS)

Study identification

• EU PAS number:
  EUPAS33124
• Study ID:
  48580
• Official title and acronym:
  Cidofovir Exposure Registry Study (CERS)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Germany

  Spain

  United Kingdom
• Study description:
  EMA requested Tillomed to conduct a PASS of Cidofovir to identify the indications and patient populations for the use of Cidofovir, as well as to evaluate patterns and compare rates of adverse events occurring in the on label group with events occurring in the off label group, and to assess the patient outcome following treatment in the specified indication. Countries involved in this joint PASS are the United Kingdom, Germany, Belgium and Spain.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:21/12/2016

Actual:06/03/2017

Study start date

Planned:03/07/2017

Actual:14/08/2019

Date of final study report

Planned:30/11/2024

Actual:30/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Tillomed Laboratories Ltd

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)
• Regulatory procedure number:
  DE/H/6139/001/DC