AnemiaNCT00466063
ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox
An observational study of Anemia, run by Novartis Pharmaceuticals at 23 sites in United States.
Trial summary
This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Anemia
- What is being tested?
- Deferasirox
- How many people
- 108 participants
- Where
- 23 sitesUnited States
- Study dates
- May 2007to Jul 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 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: 200 unselected children aged from 2 to <6 years at enrolment with chronic iron overload due to repeated blood transfusions. The participating countries were selected on the basis of both a high incidence of young children with thalassemia or other transfusion dependent anemias and on the basis that the drug is approved and 'on the market' in the country selected.
Who may be able to join
- History of transfusion-dependent anemia.
- History of iron overload
Who cannot join
- Patients with non-transfusional hemosiderosis.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Akron Children's Hospital
Akron, Ohio, 44308-1062
Children's Hospital Boston
Boston, Massachusetts, 02115
The Brooklyn Hospital Center
Brooklyn, New York, 11201
Children's Memorial Hospital
Chicago, Illinois, 60614-3394
Children's Medical Center
Dayton, Ohio, 45404
Cook's Children's Medical Center
Fort Worth, Texas, 76104
East Carolina University
Greenville, North Carolina, 27858
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Penn State University / Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital Los Angeles
Los Angeles, California, 90027
St. Jude Children's Research Hospital Memphis
Memphis, Tennessee, 38105-2794
University of South Alabama Medical Center
Mobile, Alabama, 36604
Schneider Children's Hospital
New York, New York, 11040
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
Children's Hospital Oakland
Oakland, California, 94609
Oklahoma State University Health Sciences Center
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868-3874
MD Anderson Cancer Center - Orlando
Orlando, Florida, 32806
St. Joseph's Children's Hospital
Paterson, New Jersey, 07503
Stanford University Medical Center
Stanford, California, 94304
SUNY - Upstate Medical University
Syracuse, New York, 13210
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33609
About this study
Official title: A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated With Deferasirox
This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.
- Conditions
- Anemia
- Being tested
- Deferasirox
- Keywords
- Iron overload, children, deferasirox, Transfusion-dependent anemia
- Medical subject headings
- Anemia, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeferasiroxDrug
| Study group | Role | What they receive |
|---|---|---|
| ICL670 | ICL670 Receives: Drug: Deferasirox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - renal and hepatic function monitoring.
Measured: 5 years
Secondary outcomes (3)
Adverse events
Measured: 5 years
Longitudinal ferritin levels
Measured: 5 years
Assessment of auditory and ophthalmologic status
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Prospective
- Enrolment
- 108 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
- NCT00466063
- Sponsor's protocol ID
- CICL670A2411
- Status last verified
- Dec 2015
- First submitted
- 25 Apr 2007
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated With Deferasirox
- ClinicalTrials.gov ID
- NCT00466063
- Acronym / sponsor ID
- CICL670A2411
- Conditions
- Anemia
- Keywords
- Iron overload, children, deferasirox, Transfusion-dependent anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Apr 2007 (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 registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICL670 | – | Drug: DeferasiroxICL670 |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 200 unselected children aged from 2 to <6 years at enrolment with chronic iron overload due to repeated blood transfusions. The participating countries were selected on the basis of both a high incidence of young children with thalassemia or other transfusion dependent anemias and on the basis that the drug is approved and 'on the market' in the country selected.
Key inclusion criteria (2 listed)
- History of transfusion-dependent anemia.
- History of iron overload
Key exclusion criteria (2 listed)
- Patients with non-transfusional hemosiderosis.
- 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 |
|---|---|---|
| Deferasirox | Drug | ICL670 |
Primary outcome
Safety - renal and hepatic function monitoring.
Time frame: 5 years
3 secondary outcomes
Adverse events
Time frame: 5 years
Longitudinal ferritin levels
Time frame: 5 years
Assessment of auditory and ophthalmologic status
Time frame: 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 29 Dec 2015.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Novartis Pharmaceuticals at 23 sites 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 2 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 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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.
What does the primary outcome measure?
Safety - renal and hepatic function monitoring. (time frame: 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 29 Dec 2015.