An observational study in Immune Thrombocytopenic Purpura, sponsored by Amgen. Completed at 22 sites in 8 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2015-12-22.
Sponsored by Amgen · Observational
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.
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.
521 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 158 are open to participants now.
This study's enrollment of 41 is below the median of 122 across 109 observational studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Browse Purpura, Thrombocytopenic, Idiopathic studies →Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
ITP patients being treated with romiplostim will be approached for possible study participation. At each participating site, patients that meet the following criteria will be enrolled as a study subject. Adult ITP patients, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim, that has received HAT pack training and is available at a standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training, the patient provides informed consent.
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Exclusion Criteria:
-No exclusion criteria for this observational study
single arm study
Successful self administration of romiplostim
to estimate the proportion of subjects and caregivers who administer romiplostim correctly after being trained with the HAT pack.
Time frame: First Standard of Care visit post Home Administration Training (range 2-8 weeks)
successful reconstitution of romiplostim
A yes/no indicator of whether the subject or caregiver reconstitutes romiplostim correctly.
Time frame: 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
The difference between the prescribed and administered dose of romiplostim, expressed as a %.
Time frame: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Injects romiplostim
A yes/no indicator of whether the subject or caregiver injects romiplostim successfully.
Time frame: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Administers romiplostim
A yes/no indicator of whether the subject or caregiver administers romiplostim correctly.
Time frame: Follow up visits (up to 16 weeks post enrolment)
The record gives a start of Jul 2014, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Purpura, Thrombocytopenic, Idiopathic →