Primary Immune Thrombocytopenia Treated with Romiplostim (20140451)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17010
• EU PAS number:
  EUPAS11186
• Study ID:
  17010
• Official title and acronym:
  Primary Immune Thrombocytopenia Treated with Romiplostim (20140451)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 11/07/2014

Study start date

Actual: 18/09/2015

Data analysis start date

Planned: 22/01/2016

Actual: 22/01/2016

Date of final study report

Planned: 31/12/2016

Actual: 03/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original romiplostim 20140451.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)