Transfusional Iron OverloadNCT01838291
Active Drug Surveillance Program of Ferriprox Use
An observational study of Transfusional Iron Overload, run by ApoPharma at 14 sites in 5 countries.
Trial summary
Observational, open label, prospective, multi-center, post-marketing drug surveillance program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transfusional Iron Overload
- How many people
- 294 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Jun 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Egypt7 sites
Hematology Unit, Mansoura University Children Hospital
Al Mansurah
Hematology Unit, El-Shatby Children Hospital, Alexandria University
Alexandria
Hematology Unit, Assiut University Hospital
Asyut
Ain Shams University
Cairo
Tanta University Hospital
Tanta
Hematology/Oncology Unit ; Zagazig University Children Hospital
Zagazig
Zagazig University; Thalassemia Association
Zagazig
Turkey (Türkiye)3 sites
Çukurova Üniversitesi Tip Fakültesi, Çocuk Hematolojie Bilim Dali
Adana
Akdeniz Üniversitesi Hastanesi, Çocuk Sağliği, Hematolojie Kliniği
Antalya
Ïstanbul Üniversitesi Tip. Fak. Hastanesi, Çocuk Sağliği, Hematolojie Kliniği
Istanbul
Saudi Arabia2 sites
King Abdulaziz University Hospital (KAAUH)
Jeddah
Maternity and Children's Hospital
Maddinah
Cyprus1 site
Thalassemia Center of North Cyprus Turkish Republic (KKTC)
Nicosia
Oman1 site
Department of Child Health, College of Medicine and Health Sciences, Sultan Qaboos University Hospital
Muscat
About this study
Observational, open label, prospective, multi-center, post-marketing drug surveillance program.
Read the 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.
- Conditions
- Transfusional Iron Overload
- Keywords
- Ferriprox, Deferiprone, DFP, L1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients on Ferriprox therapy <1 month | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline to 12 Months
Secondary outcomes (2)
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*.
Measured: 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).
Measured: Baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJun 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusional Iron OverloadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- ApoPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando Tricta, MD, Study chair, ApoPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838291
- Sponsor's protocol ID
- LA35-PM
- Status last verified
- Apr 2013
- First submitted
- 15 Apr 2013
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Drug Surveillance Program of Ferriprox Use
- ClinicalTrials.gov ID
- NCT01838291
- Acronym / sponsor ID
- LA35-PM
- Conditions
- Transfusional Iron Overload
- Keywords
- Ferriprox, Deferiprone, DFP, L1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- ApoPharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on Ferriprox therapy <1 month | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients.
Time frame: 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.
Time frame: 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.
2 secondary outcomes
Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice.
Time frame: Baseline to 12 Months
Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice.
Time frame: Baseline to 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Tricta, MD study chair
ApoPharma
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusional Iron Overload, run by ApoPharma at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Egypt, Turkey (Türkiye), Saudi Arabia, Cyprus, Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients. (time frame: Baseline to 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.