Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training

Completed

• Conditions: Immune Thrombocytopenic Purpura

• Registration Number: NCT02085993
• Lead Sponsor: Amgen

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.

Study Timeline

• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Study Start: 2014-07
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 exclusion criteria for this observational study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom