Status:

COMPLETED

Active Drug Surveillance Program of Ferriprox Use

Lead Sponsor:

ApoPharma

Conditions:

Transfusional Iron Overload

Eligibility:

All Genders

Brief Summary

Observational, open label, prospective, multi-center, post-marketing drug surveillance program.

Detailed Description

A post-marketing, drug surveillance program evaluating the use, monitoring, benefits and adverse effects of Ferriprox under clinical conditions in newly treated patients.

Eligibility Criteria

Inclusion

  • Main
  • Patients who started Ferriprox therapy less than one month or are to initiate Ferriprox therapy at the time of enrolment into the program.
  • Main

Exclusion

  • Patients treated with Ferriprox for more than one month prior to enrolment.

Key Trial Info

Start Date :

June 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2013

Estimated Enrollment :

294 Patients enrolled

Trial Details

Trial ID

NCT01838291

Start Date

June 1 2010

End Date

April 1 2013

Last Update

April 24 2013

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Thalassemia Center of North Cyprus Turkish Republic (KKTC)

Nicosia, Cyprus

2

Hematology Unit, Mansoura University Children Hospital

Al Mansurah, Egypt

3

Hematology Unit, El-Shatby Children Hospital, Alexandria University

Alexandria, Egypt

4

Hematology Unit, Assiut University Hospital

Asyut, Egypt