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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on Ferriprox therapy <1 month |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Baseline to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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*. | Baseline to 12 Months |
| Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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Apporximately 300 patients who have recently started treatment with treatment with Ferriprox (less than one month prior to enrolment) or who are naive to Ferriprox treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Tricta, MD | ApoPharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thalassemia Center of North Cyprus Turkish Republic (KKTC) | Nicosia | Cyprus | ||||
| Hematology Unit, Mansoura University Children Hospital |
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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). |
| Baseline to 12 Months |
| Al Mansurah |
| Egypt |
| Hematology Unit, El-Shatby Children Hospital, Alexandria University | Alexandria | Egypt |
| Hematology Unit, Assiut University Hospital | Asyut | Egypt |
| Ain Shams University | Cairo | Egypt |
| Tanta University Hospital | Tanta | Egypt |
| Hematology/Oncology Unit ; Zagazig University Children Hospital | Zagazig | Egypt |
| Zagazig University; Thalassemia Association | Zagazig | Egypt |
| Department of Child Health, College of Medicine and Health Sciences, Sultan Qaboos University Hospital | Muscat | Oman |
| King Abdulaziz University Hospital (KAAUH) | Jeddah | Saudi Arabia |
| Maternity and Children's Hospital | Maddinah | Saudi Arabia |
| Çukurova Üniversitesi Tip Fakültesi, Çocuk Hematolojie Bilim Dali | Adana | Turkey (Türkiye) |
| Akdeniz Üniversitesi Hastanesi, Çocuk Sağliği, Hematolojie Kliniği | Antalya | Turkey (Türkiye) |
| Ïstanbul Üniversitesi Tip. Fak. Hastanesi, Çocuk Sağliği, Hematolojie Kliniği | Istanbul | Turkey (Türkiye) |