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
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen, Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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)