VIR-Life: Prospective assessment of the real-life treatment outcomes of six years of Viread® in CHB following-up on the German Multicenter Non-Interventional Study GEMINIS

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17262
• EU PAS number:
  EUPAS4215
• Study ID:
  17262
• Official title and acronym:
  VIR-Life: Prospective assessment of the real-life treatment outcomes of six years of Viread® in CHB following-up on the German Multicenter Non-Interventional Study GEMINIS
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The real-life treatment outcomes of Viread® have been investigated in GEMINIS for a period of 3 years. VIR-Life is the roll-over non-interventional study from GEMINIS to allow the prospective evaluation of the real-life treatment outcomes for additional 3 years. The primary objective of this study is as follows:Prospectively describe the virological response, defined as HBV-DNA concentration, during 6 years Viread® treatment for CHB in a real life setting. The secondary objectives of this study are to evaluate the: Safety and tolerability of 6 years of Viread® in CHB in a real life setting (Adverse drug reactions (AR) (unrelated Adverse Events (AEs) will also be listed in the report), Renal safety, Estimated creatinine clearance (eCrCl), Serum creatinine level, Serum phosphorus level),and histological improvement of the liver.Duration of Study: 3 years after rolling over from GEMINISStudy Size: 150 patientsLocation: Germany, 23 sites
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 23 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/05/2013

Actual: 15/05/2013

Study start date

Planned: 17/07/2013

Actual: 29/07/2013

Data analysis start date

Planned: 18/06/2014

Actual: 22/06/2015

Date of interim report, if expected

Planned: 30/09/2014

Actual: 21/09/2015

Date of final study report

Planned: 28/04/2017

Actual: 16/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences GmbH

Study protocol

Initial protocol

protocol GS-DE-174-0225 FINAL COMPLETE

Regulatory

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