Active Drug Surveillance Program of Ferriprox Use

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01838291

Enrollment

294

Registered

2013-04-24

Start date

2010-06-30

Completion date

2013-04-30

Last updated

2013-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusional Iron Overload

Keywords

Ferriprox, Deferiprone, DFP, L1

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients.	Baseline to 12 Months	Evaluation of dose of Ferriprox includes the frequency of administration of chelator(s).
Evaluation of regimen of Ferriprox administration, and if applicable concurrent chelator(s) in newly treated patients.	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

Measure	Time frame	Description
Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice.	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\*.
Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice.	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).

Countries

Cyprus, Egypt, Oman, Saudi Arabia, Turkey (Türkiye)

Outcome results