Clinical trial NCT02085993: Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training
Official title: A Cross-sectional Study of Patients With Immune Thrombocytopenic Purpura and Caregivers to Estimate the Proportion Who Administer Romiplostim Correctly After Receipt of Home Administration Training Materials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenic Purpura
Keywords: romiplostim,
Nplate,
immune thrombocytopenic purpura
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-03-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful self administration of romiplostim
timeFrame: First Standard of Care visit post Home Administration Training (range 2-8 weeks)
Secondary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: Administers romiplostim
timeFrame: Follow up visits (up to 16 weeks post enrolment)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Ghent
country: Belgium
facility: Research Site
city: Créteil Cedex
country: France
facility: Research Site
city: Limoges Cedex
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Paris cedex 12
country: France
facility: Research Site
city: Pessac Cedex
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Kronach
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Kalamata
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Veldhoven
country: Netherlands
facility: Research Site
city: Avila
country: Spain
facility: Research Site
state: Castilla León
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: