Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01838291
Other study ID # LA35-PM
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT00560820 - Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload Phase 1
Completed NCT00390858 - A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload. Phase 2
Completed NCT01039636 - Safety and Pharmacokinetic Study of Escalating Multiple Doses of an Iron Chelator in Patients With Iron Overload Phase 1
Completed NCT00600938 - Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload Phase 2
Completed NCT00673608 - Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload Phase 4
Withdrawn NCT01927913 - Treatment of Iron Overload Requiring Chelation Therapy Phase 2
Completed NCT01241357 - High-Tc Susceptometer to Monitor Transfusional Iron Overload Phase 2
Completed NCT01044186 - A Protocol to Allow Treatment With ICL670 for Patients With or at Risk of Life-threatening Complications of Transfusional Iron Overload Who Are Unable to Tolerate Other Iron Chelators Because of Documented Severe Toxicity Phase 2
Completed NCT00379483 - Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload Phase 2
Terminated NCT01326845 - Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study Phase 4
Completed NCT01186419 - Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload Phase 2
Terminated NCT01363908 - Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload Phase 2