Active Drug Surveillance Program of Ferriprox Use

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01838291
• Date of registration: 15/04/2013
• Prospective Registration: No
• Primary sponsor: ApoPharma
• Public title: Active Drug Surveillance Program of Ferriprox Use
• Scientific title: Active Drug Surveillance Program of Ferriprox Use
• Date of first enrolment: June 2010
• Target sample size: 294
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01838291
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Cyprus, Egypt, Oman, Saudi Arabia, Turkey

Contacts

• Name: Fernando Tricta, MD
• Affiliation: ApoPharma

Key inclusion & exclusion criteria

Main Inclusion Criteria:

- 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 Criteria:

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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Transfusional Iron Overload

Primary Outcome(s)

Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients. [Time Frame: Baseline to 12 Months]

Evaluation of regimen of Ferriprox administration, and if applicable concurrent chelator(s) in newly treated patients. [Time Frame: Baseline to 12 Months]

Secondary Outcome(s)

Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice. [Time Frame: Baseline to 12 Months]

Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice. [Time Frame: Baseline to 12 Months]

Secondary ID(s)

LA35-PM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors