An observational study to assess persistence on treatment, adherence, and patient-reported outcomes during the treatment of chronic hepatitis C genotype 1 infected patients with Boceprevir added to Peginterferon plus Ribavirin in Italy (MK-3034-137)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47225
• EU PAS number:
  EUPAS6019
• Study ID:
  47225
• Official title and acronym:
  An observational study to assess persistence on treatment, adherence, and patient-reported outcomes during the treatment of chronic hepatitis C genotype 1 infected patients with Boceprevir added to Peginterferon plus Ribavirin in Italy (MK-3034-137)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This study is being done to evaluate persistence of triple-therapy treatment in Italian participants with genotype 1 (GT1) chronic hepatitis C (CHC) virus infections. Participants will be managed as per the clinical judgment of the treating physician with boceprevir (BOC) combined with pegylated interferon plus ribavirin (PR) in a real-life setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Univ Federico II Napoli

Study timelines

Date when funding contract was signed

Actual: 16/09/2013

Study start date

Planned: 07/04/2014

Actual: 16/04/2014

Data analysis start date

Planned: 01/07/2016

Actual: 29/01/2016

Date of final study report

Planned: 01/03/2017

Actual: 27/10/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable