Active Drug Surveillance Program of Ferriprox Use

NCT01838291 | Completed

• 1 other identifier: LA35-PM
• Study Type: observational
• Target: 294
• Locations: 5 countries
• Sites: 14

Brief Summary

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

Conditions

Transfusional Iron Overload

Keywords

Ferriprox; Deferiprone; DFP; L1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice.

  Baseline to 12 Months

• Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice.

  Baseline to 12 Months

Study Arms (1)

Patients on Ferriprox therapy <1 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who started Ferriprox therapy less than one month or are to initiate Ferriprox therapy at the time of enrolment into the program.

You may not qualify if:

• Patients treated with Ferriprox for more than one month prior to enrolment.

Sponsors & Collaborators

• ApoPharma: lead

Study Sites (14)

Thalassemia Center of North Cyprus Turkish Republic (KKTC)

Nicosia, Cyprus

Location

Hematology Unit, Mansoura University Children Hospital

Al Mansurah, Egypt

Location

Hematology Unit, El-Shatby Children Hospital, Alexandria University

Alexandria, Egypt

Location

Hematology Unit, Assiut University Hospital

Asyut, Egypt

Location

Ain Shams University

Cairo, Egypt

Location

Tanta University Hospital

Tanta, Egypt

Location

Hematology/Oncology Unit ; Zagazig University Children Hospital

Zagazig, Egypt

Location

Zagazig University; Thalassemia Association

Zagazig, Egypt

Location

Department of Child Health, College of Medicine and Health Sciences, Sultan Qaboos University Hospital

Muscat, Oman

Location

King Abdulaziz University Hospital (KAAUH)

Jeddah, Saudi Arabia

Location

Maternity and Children's Hospital

Maddinah, Saudi Arabia

Location

Çukurova Üniversitesi Tip Fakültesi, Çocuk Hematolojie Bilim Dali

Adana, Turkey (Türkiye)

Location

Akdeniz Üniversitesi Hastanesi, Çocuk Sağliği, Hematolojie Kliniği

Antalya, Turkey (Türkiye)

Location

Ïstanbul Üniversitesi Tip. Fak. Hastanesi, Çocuk Sağliği, Hematolojie Kliniği

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Fernando Tricta, MD

  ApoPharma

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 24, 2013
• Study Start: June 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

SA (2); TU (3); OM (1); CY (1); EG (7)