Immune Thrombocytopenic Purpura
Conditions
Keywords
romiplostim,, Nplate,, immune thrombocytopenic purpura
Brief summary
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.
Detailed description
This cross-sectional study involves direct observation by a healthcare professional of a series of subjects and caregivers in the act of administering romiplostim at their first standard-of-care visit occurring 4 weeks after training with the HAT pack. Further observations, if they occur, will also be recorded in the study if made within 16 weeks of enrolment. (Additional observations are voluntary and are not required for study participation; they occur only if the healthcare professional requests them.) Additionally, data will be collected from the subjects' dose diary at the first standard of care visit to ensure there were no problems with administration while not at the clinic.
Interventions
None listed
Sponsors
Amgen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* (1) adult ITP patient, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim, * (2) has received HAT pack training, * (3) available at standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training, * (4) patient provides informed consent.
Exclusion criteria
-No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful self administration of romiplostim | First Standard of Care visit post Home Administration Training (range 2-8 weeks) | to estimate the proportion of subjects and caregivers who administer romiplostim correctly after being trained with the HAT pack. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| successful reconstitution of romiplostim | First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment) | A yes/no indicator of whether the subject or caregiver reconstitutes romiplostim correctly. |
| Accuracy in administering the prescribed dose of romiplostim | First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment) | The difference between the prescribed and administered dose of romiplostim, expressed as a %. |
| Injects romiplostim | First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment) | A yes/no indicator of whether the subject or caregiver injects romiplostim successfully. |
| Administers romiplostim | Follow up visits (up to 16 weeks post enrolment) | A yes/no indicator of whether the subject or caregiver administers romiplostim correctly. |
Countries
Austria, Belgium, France, Germany, Greece, Netherlands, Spain, United Kingdom
Outcome results
None listed