Clinical Trial: ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated With Deferasirox
Brief Summary: This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Safety - renal and hepatic function monitoring. [ Time Frame: 5 years ]
Original Primary Outcome: Safety - renal and hepatic function monitoring.
Current Secondary Outcome:
- Adverse events [ Time Frame: 5 years ]
- Longitudinal ferritin levels [ Time Frame: 5 years ]
- Assessment of auditory and ophthalmologic status [ Time Frame: 5 years ]
Original Secondary Outcome:
- Adverse events
- Longitudinal ferritin levels
- Assessment of auditory and ophthalmologic status
Information By: Novartis
Dates:
Date Received: April 25, 2007
Date Started: May 2007
Date Completion:
Last Updated: December 26, 2015
Last Verified: December 2015
