Practicalities of Using Boceprevir and Early Responses to Treatment: Experience of the First Eighteen Months In the UK. The Boceprevir Real LIfe Treatment (BRIT) study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6373
• EU PAS number:
  EUPAS3669
• Study ID:
  6373
• Official title and acronym:
  Practicalities of Using Boceprevir and Early Responses to Treatment: Experience of the First Eighteen Months In the UK. The Boceprevir Real LIfe Treatment (BRIT) study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Evaluate the outcomes of the first two years' use of boceprevir in the UK and the early responses to treatment. This will be a retrospective study, based on data from the records of patients who received up to 12 weeks’ treatment for hepatitis C (genotype 1 infection) within a 2-year period.
• Study status:
  Planned

Research institutions and networks

Institutions

Merck & Co.

Chelsea and Westminster Hospital

Royal Free Hospital

Freeman Hospital Newcastle upon Tyne, Royal Bournemouth Hospital Bournemouth, Queen Elizabeth Hospital Birmingham, Derriford Hospital Plymouth, Glasgow Royal Infirmary Glasgow, Stirling Community Hospital Stirling, Chelsea & Westminster Hospital London, Royal Free Hospital London, Guy's & St Thomas' Hospital London

Study timelines

Date when funding contract was signed

Planned: 05/11/2012

Study start date

Planned: 25/03/2013

Date of interim report, if expected

Planned: 17/04/2014

Actual: 04/09/2013

Date of final study report

Planned: 14/08/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MSD

Study protocol

Initial protocol

10'4'13 BRIT Study_3rd amendment

Regulatory

• Was the study required by a regulatory body?:
  No