Transfusional Iron OverloadPhase 2NCT00379483
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
A Phase 2 study testing Deferasirox in people with Transfusional Iron Overload, run by Novartis Pharmaceuticals at 4 sites in Italy.
Trial summary
A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfusional Iron Overload
- What is being tested?
- Deferasirox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesItaly
- Study dates
- Jul 2002to Apr 2003
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox
Who cannot join
- Pregnant or breast feeding patients
- Patients being considered by the investigator potentially unreliable and/or a history of non-compliance
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Novartis Investigative Site
Cagliari
Novartis Investigative Site
Genova
Novartis Investigative Site
Milan
Novartis Investigative Site
Torino
About this study
A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.
The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.
- Conditions
- Transfusional Iron Overload
- Being tested
- Deferasirox
- Keywords
- Transfusional iron overload, Deferasirox
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 |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Deferasirox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment
Measured: at 3, 4, 5 years
Secondary outcomes (1)
Change in liver iron content measured by SQUID, at 3, 4, and 5 years
Measured: at 3, 4, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startJul 2002
- Primary completionApr 2003
- Study completionApr 2003
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT00379483
- Sponsor's protocol ID
- CICL670A0105E1
- Status last verified
- Mar 2015
- First submitted
- 14 Oct 2005
- Last updated
- 19 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
- ClinicalTrials.gov ID
- NCT00379483
- Acronym / sponsor ID
- CICL670A0105E1
- Conditions
- Transfusional Iron Overload
- Keywords
- Transfusional iron overload, Deferasirox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 22 Sep 2006 (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.
A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.
The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Deferasirox |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox
Key exclusion criteria (2 listed)
- Pregnant or breast feeding patients
- Patients being considered by the investigator potentially unreliable and/or a history of non-compliance
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 | Arm 1 |
Primary outcome
Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment
Time frame: at 3, 4, 5 years
1 secondary outcome
Change in liver iron content measured by SQUID, at 3, 4, and 5 years
Time frame: at 3, 4, 5 years
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 19 Mar 2015.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deferasirox in people with Transfusional Iron Overload, run by Novartis Pharmaceuticals at 4 sites in Italy.
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 1 inclusion and 2 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 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment (time frame: at 3, 4, 5 years). 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 19 Mar 2015.