Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload
Public ClinicalTrials.gov record NCT02435212. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients With Iron Overload
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment compliance and change in serum ferritin of a deferasirox granule formulation and a deferasirox dispersible tablet (DT) formulation in children and adolescents aged ≥ 2 and \< 18 years at enrolment with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to demonstrate the effect of improved compliance on iron burden. Randomization was stratified by age groups (2 to \<10 years, 10 to \<18 years) and prior iron chelation therapy (Yes/ No). There were two study phases which include a 1 year core phase where participants were randomized to a 48 week treatment period to either Deferasirox DT or granules, and an optional extension phase where all participants received the granules up to 5 years. Participants who demonstrated benefit to granules or DT in the core phase, and/or expressed the wish to continue in the optional extension phase on granules, were offered this possibility until there was local access to the new formulation (granules or film-coated tablet (FCT)) or up to 5 years, whichever occurred first.
Study identification
- NCT ID
- NCT02435212
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 224 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 21, 2015 (Actual)
- Primary completion
- May 31, 2018 (Actual)
- Completion
- Jan 15, 2024 (Actual)
- Last update posted
- Sep 19, 2024
2015 – 2024
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Oakland | California | 94609-1809 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30342 | — |
| Novartis Investigative Site | Chicago | Illinois | 60611 | — |
| Novartis Investigative Site | New York | New York | 10021 | — |
| Weill Cornell Medical College SC - | New York | New York | 10021 | — |
| Childrens Hospital at Montefiore | The Bronx | New York | 10467 | — |
| Novartis Investigative Site | The Bronx | New York | 10467 | — |
| Childrens Hospital of Philadelphia Onc. Dept | Philadelphia | Pennsylvania | 19104 4399 | — |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 4399 | — |
| Medical Uni of South Carolina Medical Uni of South Carolina | Charleston | South Carolina | 29425 | — |
| Novartis Investigative Site | Charleston | South Carolina | 29425 | — |
| Novartis Investigative Site | Memphis | Tennessee | 38105 | — |
| St. Jude Children's Research Hospital Memphis St Jude | Memphis | Tennessee | 38105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02435212, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 19, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02435212 live on ClinicalTrials.gov.