Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Patients (P08518)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24508
• EU PAS number:
  EUPAS2768
• Study ID:
  24508
• Official title and acronym:
  Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Patients (P08518)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  United Kingdom
• Study description:
  This will be an observational study of the routine clinical management of patients infected with Chronic Hepatitis C (CHC) genotype-1. Primary data collection on physicians treating CHC and patients infected with CHC will be performed in approximately 4 European countries (the exact number and final selection of countries will depend on market uptake of Victrelis™(Boceprevir). This study is not intended to change the patient/physician relationship, nor influence the physician’s drug prescription or therapeutic management of the patient. Physicians that treat CHC will provide aggregated site level information about current patterns of CHC treatment via a drug utilization questionnaire. Baseline patient information and data on the occurrence, clinical management of protocol-defined HOIs (anemia, neutropenia, thrombocytopenia, rash) will be collected via eCRF among patients initiating Victrelis in combination with P-R, Incivo in combination with P-R or P-R only regimens. Data will be collected every 8 weeks for up to 48 weeks of treatment.
• Study status:
  Finalised

Research institutions and networks

Institutions

ICON Commercialisation & Outcomes

Germany

Ireland

Multiple centres: 80 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 09/09/2011

Actual: 20/05/2011

Study start date

Planned: 29/05/2012

Actual: 21/05/2012

Data analysis start date

Planned: 30/06/2015

Actual: 06/07/2015

Date of interim report, if expected

Planned: 16/12/2014

Date of final study report

Planned: 30/04/2016

Actual: 10/05/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck, Sharp & Dohme

Study protocol

Initial protocol

Final Redactions Applied_ P08518 Victrelis PASS Protocol

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)