Utilization of Ribavirin in Pediatric Patients with Hepatitis C Virus - Aggregated Experience of European Specialists (MK-8908-060)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22864
• EU PAS number:
  EUPAS5533
• Study ID:
  22864
• Official title and acronym:
  Utilization of Ribavirin in Pediatric Patients with Hepatitis C Virus - Aggregated Experience of European Specialists (MK-8908-060)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This is a retrospective drug utilization survey, which collects data on the prescribing behavior of physicians treating pediatric patients for hepatitis C with ribavirin. Data collection will cover the time period from July 25, 2011 to July 24, 2014 in 5 European countries: Italy, France, Spain, Germany and the United Kingdom.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Multiple centres: 10 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 25/07/2011

Study start date

Planned: 15/08/2014

Actual: 16/07/2014

Data analysis start date

Planned: 31/01/2015

Actual: 24/01/2015

Date of final study report

Planned: 10/03/2015

Actual: 19/03/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp and Dohme Corp

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)