Active Drug Surveillance Program of Ferriprox Use

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

Study Overview

• Status: Completed
• Conditions: Transfusional Iron Overload

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 Type: Observational
• Enrollment (Actual): 294

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients on Ferriprox therapy <1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: ApoPharma
• Investigators: Study Chair: Fernando Tricta, MD, ApoPharma

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: April 15, 2013
• First Submitted That Met QC Criteria: April 19, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Estimate): April 24, 2013
• Last Update Submitted That Met QC Criteria: April 19, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Ferriprox; Deferiprone; DFP; L1
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Overload
• Other Study ID Numbers: LA35-PM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No