Active Drug Surveillance Program of Ferriprox Use

Completed

• Conditions: Transfusional Iron Overload

• Registration Number: NCT01838291
• Lead Sponsor: ApoPharma

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.

Study Timeline

• Study Start: 2010-06
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-19
• Last Update Submitted: 2013-04-19
• Study First Posted: 2013-04-24
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (14)

Zagazig University; Thalassemia Association; 🇪🇬 Zagazig, Egypt

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

Maternity and Children's Hospital; 🇸🇦 Maddinah, Saudi Arabia

Department of Child Health, College of Medicine and Health Sciences, Sultan Qaboos University Hospital; 🇴🇲 Muscat, Oman

King Abdulaziz University Hospital (KAAUH); 🇸🇦 Jeddah, Saudi Arabia

Hematology Unit, Mansoura University Children Hospital; 🇪🇬 Mansoura, Egypt

Tanta University Hospital; 🇪🇬 Tanta, Egypt

Hematology/Oncology Unit ; Zagazig University Children Hospital; 🇪🇬 Zagazig, Egypt

Ain Shams University; 🇪🇬 Cairo, Egypt

Çukurova Üniversitesi Tip Fakültesi, Çocuk Hematolojie Bilim Dali; 🇹🇷 Adana, Turkey

Akdeniz Üniversitesi Hastanesi, Çocuk Sağliği, Hematolojie Kliniği; 🇹🇷 Antalya, Turkey

Ïstanbul Üniversitesi Tip. Fak. Hastanesi, Çocuk Sağliği, Hematolojie Kliniği; 🇹🇷 Istanbul, Turkey

Hematology Unit, El-Shatby Children Hospital, Alexandria University; 🇪🇬 Alexandria, Egypt

Hematology Unit, Assiut University Hospital; 🇪🇬 Assiut, Egypt