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Completed

NCT Number: NCT01838291

Active Drug Surveillance Program of Ferriprox Use

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

Completed

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Key information

Conditions

Transfusional Iron Overload

Sex eligibility

All sexes

Study type

Observational

Primary location

Thalassemia Center of North Cyprus Turkish Republic (KKTC), Nicosia, Cyprus

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline to 12 Months

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

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

    Time frame: Baseline to 12 Months

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

Secondary outcomes

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

    Time frame: Baseline to 12 Months

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

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

    Time frame: Baseline to 12 Months

    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).

Sponsors and collaborators

Lead sponsor

ApoPharma

Industry

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 24, 2013
Registry last updated
Apr 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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