An Observational Study to Evaluate the Potential Association Between ParsabivTM and Gastrointestinal Bleeding (20170561)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50484
• EU PAS number:
  EUPAS23186
• Study ID:
  50484
• Official title and acronym:
  An Observational Study to Evaluate the Potential Association Between ParsabivTM and Gastrointestinal Bleeding (20170561)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The Food and Drug Administration (FDA) required Amgen to conduct an observational study to assess the potential association between ParsabivTM (etelcalcetide) and fatal and non-fatal gastrointestinal bleeding as a post-marketing requirement. This observational study is designed to assess the potential association between ParsabivTM use and the risk of fatal and non-fatal GI bleeding in patients receiving maintenance hemodialysis, using a nested case control study design.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 28/02/2018

Study start date

Planned: 01/07/2018

Actual: 01/07/2018

Data analysis start date

Planned: 01/05/2022

Actual: 01/05/2022

Date of final study report

Planned: 31/12/2022

Actual: 28/11/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Amendment etelcalcetide 20170561 2 .pdf

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)