Active Drug Surveillance Program of Ferriprox Use

Transfusional Iron Overload Clinical Trial

Official title:

Active Drug Surveillance Program of Ferriprox Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838291
• Other study ID #: LA35-PM
• Status: Completed
• Phase: N/A
• First received: April 15, 2013
• Last updated: April 19, 2013
• Start date: June 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: ApoPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Iron Overload
• Transfusional Iron Overload

Locations

Country	Name	City	State
Cyprus	Thalassemia Center of North Cyprus Turkish Republic (KKTC)	Nicosia
Egypt	Hematology Unit, El-Shatby Children Hospital, Alexandria University	Alexandria
Egypt	Hematology Unit, Assiut University Hospital	Assiut
Egypt	Ain Shams University	Cairo
Egypt	Hematology Unit, Mansoura University Children Hospital	Mansoura
Egypt	Tanta University Hospital	Tanta
Egypt	Hematology/Oncology Unit ; Zagazig University Children Hospital	Zagazig
Egypt	Zagazig University; Thalassemia Association	Zagazig
Oman	Department of Child Health, College of Medicine and Health Sciences, Sultan Qaboos University Hospital	Muscat
Saudi Arabia	King Abdulaziz University Hospital (KAAUH)	Jeddah
Saudi Arabia	Maternity and Children's Hospital	Maddinah
Turkey	Çukurova Üniversitesi Tip Fakültesi, Çocuk Hematolojie Bilim Dali	Adana
Turkey	Akdeniz Üniversitesi Hastanesi, Çocuk Sagligi, Hematolojie Klinigi	Antalya
Turkey	Ïstanbul Üniversitesi Tip. Fak. Hastanesi, Çocuk Sagligi, Hematolojie Klinigi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
ApoPharma

Countries where clinical trial is conducted

Cyprus,  Egypt,  Oman,  Saudi Arabia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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).	Baseline to 12 Months	Yes