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

N/ACompletedNCT02085993

Amgen41 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Immune Thrombocytopenic Purpura

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (22)

Research Site

Innsbruck, Austria

Research Site

Leoben, Austria

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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