Multicenter, Non-Interventional, Retrospective, Matched Cohort Study of Patients Monoinfected with Chronic Hepatitis B and with Moderate or Severe Renal Impairment Treated with Viread® or Baraclude® (ReCoRd)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25333
• EU PAS number:
  EUPAS12897
• Study ID:
  25333
• Official title and acronym:
  Multicenter, Non-Interventional, Retrospective, Matched Cohort Study of Patients Monoinfected with Chronic Hepatitis B and with Moderate or Severe Renal Impairment Treated with Viread® or Baraclude® (ReCoRd)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  GS-EU-174-1846: The primary objective of this study was to retrospectively evaluate the safety of Viread® among adult chronic hepatitis B patients with moderate or severe renal impairment, focusing on renal events of special interest.
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Multiple centres: 55 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 23/11/2015

Actual: 23/11/2015

Study start date

Planned: 30/06/2016

Actual: 30/06/2016

Data analysis start date

Planned: 02/10/2017

Actual: 23/11/2017

Date of final study report

Planned: 30/03/2018

Actual: 05/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Europe Ltd.

Study protocol

Initial protocol

protocol+GS-EU-174-1846_v1.2_approved signed

Updated protocol

amd-1-prot GS-EU-174-1846

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)