Drug Utilization Study of eliglustat in the US population using MarketScan® Database (ELIGLC06912)

Study identification

• EU PAS number:
  EUPAS21025
• Study ID:
  29327
• Official title and acronym:
  Drug Utilization Study of eliglustat in the US population using MarketScan® Database (ELIGLC06912)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Retrospective cohort study to estimate the proportion of patients taking concomitant medications of interest including strong CYP3A inducers, strong and moderate CYP2D6 inhibitors and CYP3A inhibitors, and P-gp or CYP2D6 substrate medications prior to starting eliglustat and those who continue or start these medications concurrently while on eliglustat treatment in the US.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned:30/06/2016

Actual:30/06/2016

Study start date

Planned:30/06/2016

Actual:30/06/2016

Data analysis start date

Planned:30/06/2016

Actual:30/06/2016

Date of interim report, if expected

Planned:30/09/2016

Actual:25/09/2016

Date of final study report

Planned:30/09/2018

Actual:05/11/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi Genzyme

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)