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

December 21, 2015 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Research Site
      • Leoben, Austria, 8700
        • Research Site
  • Belgium
      • Brugge, Belgium, 8000
        • Research Site
      • Ghent, Belgium, 9000
        • Research Site
  • France
      • Créteil Cedex, France, 94010
        • Research Site
      • Limoges Cedex, France, 87042
        • Research Site
      • Montpellier, France, 34395
        • Research Site
      • Paris cedex 12, France, 75571
        • Research Site
      • Pessac Cedex, France, 33604
        • Research Site
  • Germany
      • Berlin, Germany, 12200
        • Research Site
      • Kronach, Germany, 96317
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Research Site
      • Kalamata, Greece, 24100
        • Research Site
      • Thessaloniki, Greece, 54636
        • Research Site
  • Netherlands
      • Den Haag, Netherlands, 2545 CH
        • Research Site
      • Veldhoven, Netherlands, 5504 DB
        • Research Site
  • Spain
      • Madrid, Spain, 28031
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
    • Castilla León
      • Avila, Castilla León, Spain, 05004
        • Research Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Research Site
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Research Site
      • London, United Kingdom, E1 1BB
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
single arm
single arm study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First Standard of Care visit post Home Administration Training (range 2-8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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 %.
First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
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.
First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
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.
Follow up visits (up to 16 weeks post enrolment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120269

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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