Clinical trial NCT01838291: Active Drug Surveillance Program of Ferriprox Use
Official title: Active Drug Surveillance Program of Ferriprox Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfusional Iron Overload
Keywords: Ferriprox
Deferiprone
DFP
L1
Lead sponsor: ApoPharma
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 294
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients.
timeFrame: Baseline to 12 Months
measure: Evaluation of regimen of Ferriprox administration, and if applicable concurrent chelator(s) in newly treated patients.
timeFrame: Baseline to 12 Months
Secondary outcomes:
measure: Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice.
timeFrame: Baseline to 12 Months
measure: Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice.
timeFrame: Baseline to 12 Months
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Thalassemia Center of North Cyprus Turkish Republic (KKTC)
city: Alexandria
country: Egypt
facility: Hematology Unit, El-Shatby Children Hospital, Alexandria University
city: Assiut
country: Egypt
facility: Hematology Unit, Assiut University Hospital
city: Cairo
country: Egypt
facility: Ain Shams University
city: Mansoura
country: Egypt
facility: Hematology Unit, Mansoura University Children Hospital
city: Tanta
country: Egypt
facility: Tanta University Hospital
city: Zagazig
country: Egypt
facility: Hematology/Oncology Unit ; Zagazig University Children Hospital
city: Zagazig
country: Egypt
facility: Zagazig University; Thalassemia Association
city: Muscat
country: Oman
facility: Department of Child Health, College of Medicine and Health Sciences, Sultan Qaboos University Hospital
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital (KAAUH)
city: Maddinah
country: Saudi Arabia
facility: Maternity and Children's Hospital
city: Adana
country: Turkey
facility: Çukurova Üniversitesi Tip Fakültesi, Çocuk Hematolojie Bilim Dali
city: Antalya
country: Turkey
facility: Akdeniz Üniversitesi Hastanesi, Çocuk Sağliği, Hematolojie Kliniği
city: Istanbul
country: Turkey
facility: Ïstanbul Üniversitesi Tip. Fak. Hastanesi, Çocuk Sağliği, Hematolojie Kliniği
Study officials:
affiliation: ApoPharma
name: Fernando Tricta, MD
role: STUDY_CHAIR
References: