Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Immune Thrombocytopenic Purpura
Phase: N/A
Status: Recruiting
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Overall contact: Amgen Call Center, Phone: 866-572-6436
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.
Clinical Details
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 design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Successful self administration of romiplostim
Secondary outcome: successful reconstitution of romiplostimAccuracy in administering the prescribed dose of romiplostim Injects romiplostim Administers romiplostim
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Amgen Call Center, Phone: 866-572-6436
Research Site, Innsbruck 6020, Austria; Recruiting
Research Site, Leoben 8700, Austria; Recruiting
Research Site, Brugge 8000, Belgium; Recruiting
Research Site, Gent 9000, Belgium; Recruiting
Research Site, Créteil Cedex 94010, France; Recruiting
Research Site, Limoges Cedex 87042, France; Recruiting
Research Site, Montpellier 34395, France; Recruiting
Research Site, Paris cedex 12 75571, France; Recruiting
Research Site, Pessac Cedex 33604, France; Recruiting
Research Site, Berlin 12200, Germany; Recruiting
Research Site, Kronach 96317, Germany; Recruiting
Research Site, Athens 11527, Greece; Recruiting
Research Site, Kalamata 24100, Greece; Recruiting
Research Site, Thessaloniki 54636, Greece; Recruiting
Research Site, Den Haag 2545 CH, Netherlands; Recruiting
Research Site, Veldhoven 5504 DB, Netherlands; Recruiting
Research Site, Madrid 28031, Spain; Recruiting
Research Site, Madrid 28041, Spain; Recruiting
Research Site, Leicester LE1 5WW, United Kingdom; Recruiting
Research Site, London E1 1BB, United Kingdom; Recruiting
Research Site, Avila, Castilla León 05004, Spain; Recruiting
Research Site, Majadahonda, Madrid 28222, Spain; Recruiting
Additional Information
AmgenTrials clinical trials website
Starting date: July 2014
Last updated: April 15, 2015
|