Iron OverloadNCT01376622
Changes in Pituitary Iron and Volume With Deferasirox
An observational study of Iron Overload, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands, particularly the pituitary gland, remains common in patients with transfusion dependent anemias. Read more about this study
- Who is it for?
- Ages 2 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Overload
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to 1 Jul 2011
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Transfusion Dependent Anemia
Who may be able to join
- Currently on chronic transfusion therapy.
- Duration of chronic transfusion >1 year.
- Age 2 to 25 years
- On deferasirox monotherapy for the duration of the study.
- Informed consent from legal guardian and/or patient.
- On deferasirox for a minimum of 3 months at start of study.
Who cannot join
- Sickle cell disease or sickle-beta zero genotype.
- Combination of deferasirox and another iron chelator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Changes in Pituitary Iron and Volume With Deferasirox in Transfusional Iron Overload
Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands, particularly the pituitary gland, remains common in patients with transfusion dependent anemias. We would like to establish accurate population norms of pituitary R2 and volume and understand the progression of pituitary iron in transfused patients on Deferasirox.
- Conditions
- Iron Overload
- Medical subject headings
- Iron Overload
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 |
|---|---|---|
| Chronically Transfusion Patients | Patients with transfusion dependent anemia (excluding sickle cell disease), ages 2-25, on Deferasirox chelation therapy, to be monitored over 2 years. | |
| Controls | Normal controls, ages 2-25, with no known brain abnormality or endocrine dysfunction. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startNov 2008
- Primary completion1 Jul 2011
- Study completion1 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron OverloadStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, John C. Wood, Children's Hospital Los Angeles
- Investigators
- John C Wood, MD, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376622
- Sponsor's protocol ID
- CCI-08-00143
- Status last verified
- Oct 2023
- First submitted
- 17 Jun 2011
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wood JC, Noetzl L, Hyderi A, Joukar M, Coates T, Mittelman S. Predicting pituitary iron and endocrine dysfunction. Ann N Y Acad Sci. 2010 Aug;1202:123-8. doi: 10.1111/j.1749-6632.2010.05545.x.
PubMed 20712782
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pituitary Iron and Volume With Deferasirox in Transfusional Iron Overload
- ClinicalTrials.gov ID
- NCT01376622
- Acronym / sponsor ID
- CCI-08-00143
- Conditions
- Iron Overload
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Nov 2008
- Primary completion
- 1 Jul 2011 (actual)
- Study completion
- 1 Jul 2011 (actual)
- First posted
- 20 Jun 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.
Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands, particularly the pituitary gland, remains common in patients with transfusion dependent anemias. We would like to establish accurate population norms of pituitary R2 and volume and understand the progression of pituitary iron in transfused patients on Deferasirox.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronically Transfusion Patients | – | –Patients with transfusion dependent anemia (excluding sickle cell disease), ages 2-25, on Deferasirox chelation therapy, to be monitored over 2 years. |
| Controls | – | –Normal controls, ages 2-25, with no known brain abnormality or endocrine dysfunction. |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Transfusion Dependent Anemia
Key inclusion criteria (6 listed)
- Currently on chronic transfusion therapy.
- Duration of chronic transfusion >1 year.
- Age 2 to 25 years
- On deferasirox monotherapy for the duration of the study.
- Informed consent from legal guardian and/or patient.
Key exclusion criteria (2 listed)
- Sickle cell disease or sickle-beta zero genotype.
- Combination of deferasirox and another iron chelator.
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
Not reported in the source record.
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 31 Oct 2023.
- Results publication: PubMed 20712782Wood JC, Noetzl L, Hyderi A, Joukar M, Coates T, Mittelman S. Predicting pituitary iron and endocrine dysfunction. Ann N Y Acad Sci. 2010 Aug;1202:123-8. doi: 10.1111/j.1749-6632.2010.05545.x.
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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.
John C Wood, MD, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Overload, run by Children's Hospital Los Angeles at 1 site in United States.
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 6 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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01376622, which also lists 1 linked publication.
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 31 Oct 2023.