Skip to main content
OpenTrials
Completed

NCT Number: NCT02085993

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Immune Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Innsbruck, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Successful self administration of romiplostim

    Time frame: 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 outcomes

  1. successful reconstitution of romiplostim

    Time frame: 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.

  2. Accuracy in administering the prescribed dose of romiplostim

    Time frame: 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 %.

  3. Injects romiplostim

    Time frame: 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.

  4. Administers romiplostim

    Time frame: Follow up visits (up to 16 weeks post enrolment)

    A yes/no indicator of whether the subject or caregiver administers romiplostim correctly.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2014
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.