Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training
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
1 other identifier
observational
41
8 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2014
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 22, 2015
December 1, 2015
1.3 years
March 11, 2014
December 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful self administration of romiplostim
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 Outcomes (4)
successful reconstitution of romiplostim
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
First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Injects romiplostim
First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Administers romiplostim
Follow up visits (up to 16 weeks post enrolment)
Study Arms (1)
single arm
single arm study
Eligibility Criteria
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.
You may qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (22)
Research Site
Innsbruck, 6020, Austria
Research Site
Leoben, 8700, Austria
Research Site
Bruges, 8000, Belgium
Research Site
Ghent, 9000, Belgium
Research Site
Créteil, 94010, France
Research Site
Limoges, 87042, France
Research Site
Montpellier, 34395, France
Research Site
Paris, 75571, France
Research Site
Pessac, 33604, France
Research Site
Berlin, 12200, Germany
Research Site
Kronach, 96317, Germany
Research Site
Athens, 11527, Greece
Research Site
Kalamata, 24100, Greece
Research Site
Thessaloniki, 54636, Greece
Research Site
The Hague, 2545 CH, Netherlands
Research Site
Veldhoven, 5504 DB, Netherlands
Research Site
Ávila, Castille and León, 05004, Spain
Research Site
Madrid, Madrid, 28031, Spain
Research Site
Madrid, Madrid, 28041, Spain
Research Site
Majadahonda, Madrid, 28222, Spain
Research Site
Leicester, LE1 5WW, United Kingdom
Research Site
London, E1 1BB, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2014
First Posted
March 13, 2014
Study Start
July 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
December 22, 2015
Record last verified: 2015-12