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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 romiplostim

Accuracy 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

Page last updated: August 23, 2015

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