A Prospective cohort study on the use of Sofosbuvir-based regimens in HCV-infected patients in clinical practice in France (HELIOS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50593
• EU PAS number:
  EUPAS11074
• Study ID:
  50593
• Official title and acronym:
  A Prospective cohort study on the use of Sofosbuvir-based regimens in HCV-infected patients in clinical practice in France (HELIOS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  GS-FR-334-1530: This was a multi-centre, prospective, non interventional cohort study. This study collected and evaluated information on safety and efficacy of sofosbuvir-based regimens in routine clinical practice in France.
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Multiple centres: 45 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 30/09/2014

Actual: 30/09/2014

Study start date

Planned: 05/10/2015

Actual: 13/10/2015

Data analysis start date

Planned: 30/11/2018

Actual: 23/04/2021

Date of final study report

Planned: 31/12/2021

Actual: 26/10/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

GS-FR-334-1530 Protocol-5Dec2014 - Final

Updated protocol

amd-2-prot-GS-FR-334-1530-09aug2017

Regulatory

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