Transfusional HemosiderosisNCT01394029
Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox
An observational study of Transfusional Hemosiderosis, run by Novartis Pharmaceuticals at 10 sites in 4 countries.
Trial summary
This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Transfusional Hemosiderosis
- What is being tested?
- deferasirox
- How many people
- 120 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Jul 2011to Oct 2015
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.
Who may be able to join
- -Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.
- (the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.
Who cannot join
- Patients with non-transfusional hemosiderosis
- Patients treated with deferasirox in an interventional clinical trial
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United Kingdom4 sites
Novartis Investigative Site
London, N18 1QX
Novartis Investigative Site
London, N19 5NF
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
West Midlands, Birmingham, B4 6NH
Spain3 sites
Novartis Investigative Site
Barcelona, Catalonia, 08916
Novartis Investigative Site
Barcelona, Catalonia
Novartis Investigative Site
Oviedo, Principality of Asturias, 33006
Egypt2 sites
Novartis Investigative Site
Cairo, Cairo Governorate, 11566
Novartis Investigative Site
Cairo
About this study
Official title: International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting
This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.
- Conditions
- Transfusional Hemosiderosis
- Being tested
- deferasirox
- Keywords
- iron overload, iron chelation, deferasirox, observational
- Medical subject headings
- Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deferasiroxDrug
Also called ICL670
| Study group | Role | What they receive |
|---|---|---|
| deferasirox | Not described Receives: Drug: deferasirox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Creatinine and liver enzyme levels
Observed over 3 years for each patient
Measured: 3 years
Adverse Drug Reactions
Observed over 3 years for each patient
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusional HemosiderosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394029
- Sponsor's protocol ID
- CICL670A2301
- Status last verified
- Feb 2016
- First submitted
- 12 Jul 2011
- Last updated
- 2 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting
- ClinicalTrials.gov ID
- NCT01394029
- Acronym / sponsor ID
- CICL670A2301
- Conditions
- Transfusional Hemosiderosis
- Keywords
- iron overload, iron chelation, deferasirox, observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Jul 2011 (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.
This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deferasirox | – | Drug: deferasirox |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.
Key inclusion criteria (2 listed)
- -Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.
- (the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.
Key exclusion criteria (3 listed)
- Patients with non-transfusional hemosiderosis
- Patients treated with deferasirox in an interventional clinical trial
- Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deferasiroxAlso: ICL670 | Drug | deferasirox |
Primary outcome
Serum Creatinine and liver enzyme levels
Time frame: 3 years
Observed over 3 years for each patient
Adverse Drug Reactions
Time frame: 3 years
Observed over 3 years for each patient
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 2 Feb 2016.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusional Hemosiderosis, run by Novartis Pharmaceuticals at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Spain, Egypt, Jordan. 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?
Serum Creatinine and liver enzyme levels (time frame: 3 years). 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 2 Feb 2016.