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

Immune Thrombocytopenic Purpura Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085993
• Other study ID #: 20120269
• Status: Completed
• Phase: N/A
• First received: March 11, 2014
• Last updated: December 21, 2015
• Start date: July 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Institutional Review BoardNetherlands: Independent Ethics CommitteeUnited Kingdom: Research Ethics CommitteeFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéGreece: National Organization of MedicinesSpain: Ministry of HealthGermany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Locations

Country	Name	City	State
Austria	Research Site	Innsbruck
Austria	Research Site	Leoben
Belgium	Research Site	Brugge
Belgium	Research Site	Ghent
France	Research Site	Créteil Cedex
France	Research Site	Limoges Cedex
France	Research Site	Montpellier
France	Research Site	Paris cedex 12
France	Research Site	Pessac Cedex
Germany	Research Site	Berlin
Germany	Research Site	Kronach
Greece	Research Site	Athens
Greece	Research Site	Kalamata
Greece	Research Site	Thessaloniki
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Veldhoven
Spain	Research Site	Avila	Castilla León
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Majadahonda	Madrid
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Greece,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	successful reconstitution of romiplostim	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)	No
Secondary	Accuracy in administering the prescribed dose of romiplostim	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)	No
Secondary	Injects romiplostim	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)	No
Secondary	Administers romiplostim	A yes/no indicator of whether the subject or caregiver administers romiplostim correctly.	Follow up visits (up to 16 weeks post enrolment)	No

External Links

•   AmgenTrials clinical trials website