Active Drug Surveillance Program of Ferriprox Use

ApoPharma294 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

294

Conditions

Transfusional Iron Overload

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (14)

Thalassemia Center of North Cyprus Turkish Republic (KKTC)

Nicosia, Cyprus

Hematology Unit, Mansoura University Children Hospital

Al Mansurah, Egypt

Outcomes

Primary Outcomes

Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients.

Evaluation of dose of Ferriprox includes the frequency of administration of chelator(s).

Time frame: Baseline to 12 Months

Evaluation of regimen of Ferriprox administration, and if applicable concurrent chelator(s) in newly treated patients.

Evaluation of how Ferriprox is prescribed/received by the patient: as monotherapy, simultaneous with deferoxamine, alternate with deferoxamine, simultaneous with deferasirox, alternate with deferasirox.

Time frame: Baseline to 12 Months

Secondary Outcomes

Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice.

Beneficial effects of Ferriprox will be assessed based on the changes in: serum ferritin and cardiac iron concentration as assessed by MRI T2\*.

Time frame: Baseline to 12 Months

Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice.

Adverse effects of Ferriprox will be assessed based on: frequency of absolute neutrophil count (ANC) monitoring, occurrence of neutropenia or agranulocytosis and occurrence of other adverse events (AEs) or adverse drug reactions (ADRs).

Time frame: Baseline to 12 Months

Data from ClinicalTrials.gov

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