A cross-sectional study of patients with immune thrombocytopenic purpura and caregivers to estimate the proportion who administer romiplostim correctly after receipt of home administration training materials (20120269)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20208
• EU PAS number:
  EUPAS6658
• Study ID:
  20208
• Official title and acronym:
  A cross-sectional study of patients with immune thrombocytopenic purpura and caregivers to estimate the proportion who administer romiplostim correctly after receipt of home administration training materials (20120269)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Greece

  Netherlands

  Spain

  United Kingdom
• Study description:
  The objective of this study is to estimate the proportion of subjects and caregivers who administer romiplostim correctly after being trained with the home administration training pack. This is a cross-sectional study with direct observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects’ dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 13/12/2013

Study start date

Planned: 04/08/2014

Actual: 07/07/2014

Data analysis start date

Planned: 07/03/2016

Actual: 03/02/2016

Date of final study report

Planned: 12/04/2016

Actual: 12/05/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

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)