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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-11-30

Brief Summary

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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

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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.

Conditions

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Immune Thrombocytopenic Purpura

Keywords

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romiplostim, Nplate, immune thrombocytopenic purpura

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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single arm

single arm study

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

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20120269

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

single arm

Eligibility Criteria

Inclusion Criteria

Sponsors

Amgen

Responsible Party

Principal Investigators

MD

Locations

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Other Identifiers

20120269