Study Complete
Sponsor ID
20120269

Study of patients with ITP estimating the proportion administering Romiplostim correctly after receiving home administration training

Sponsor ID
20120269
Clinicaltrials.gov ID
NCT02085993
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. 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.

Additional Study Details

Phase
N/A
Product
romiplostim
Type
Observational
Masking
N/A
Enrollment
41
Additional Study Details

Protocol Summary

Primary Outcome Measures

Successful self administration of romiplostim

Timeframe: First Standard of Care visit post Home Administration Training (range 2-8 weeks)

Secondary Outcome Measures

successful reconstitution of romiplostim

Timeframe: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)

Accuracy in administering the prescribed dose of romiplostim

Timeframe: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)

Injects romiplostim

Timeframe: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)

Administers romiplostim

Timeframe: Follow up visits (up to 16 weeks post enrolment)

Locations

Location
Status
Contact Us
Location
Research Site
Avila, Castilla León, Spain, 05004
Status
Recruiting
Location
Research Site
Brugge, Belgium, 8000
Status
Recruiting
Location
Research Site
Leoben, Austria, 8700
Status
Recruiting
Location
Research Site
Madrid, Madrid, Spain, 28031
Status
Recruiting
Location
Research Site
Ghent, Belgium, 9000
Status
Recruiting
Location
Research Site
Majadahonda, Madrid, Spain, 28222
Status
Recruiting
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