← Back to Search

Iron Chelator

Deferasirox Formulations for Iron Overload

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 1, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, and 45 (13 samples)
Awards & highlights

Study Summary

This trial will compare the compliance and effectiveness of two different deferasirox formulations in children and adolescents with transfusion-dependent anemia.

Who is the study for?
This trial is for children and teens aged 2 to less than 18 with transfusion-dependent anemia and iron overload, needing chelation therapy. They must have a serum ferritin level over 1000 ng/mL and not suffer from certain kidney, liver or gastrointestinal conditions that could affect treatment.Check my eligibility
What is being tested?
The study compares two forms of the drug Deferasirox: granules versus DT formulation, in managing iron levels in young patients. It includes a one-year core phase where participants are randomly assigned to either form, followed by an optional extension up to five years with granules.See study design
What are the potential side effects?
Deferasirox can cause side effects like digestive issues (nausea, vomiting), increased liver enzymes which may indicate liver damage, kidney problems reflected by changes in urine tests, and potential hearing or vision disturbances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 1, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, and 45 (13 samples)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 1, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, and 45 (13 samples) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in serum ferritin in ICT naive patients.
Compliance (using stick/pack tablet count).
Secondary outcome measures
Assess additional safety, as measured by frequency and severity of adverse for granules during extension phase
Change in serum ferritin in ICT naive patients
Change in serum ferritin in pre-treated patients
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2Experimental Treatment1 Intervention
Group II: Arm 1Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deferasirox granule formulation
2015
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,481 Total Patients Enrolled
21 Trials studying Anemia
2,972 Patients Enrolled for Anemia

Media Library

Deferasirox DT formulation (Iron Chelator) Clinical Trial Eligibility Overview. Trial Name: NCT02435212 — Phase 2
Anemia Research Study Groups: Arm 1, Arm 2
Anemia Clinical Trial 2023: Deferasirox DT formulation Highlights & Side Effects. Trial Name: NCT02435212 — Phase 2
Deferasirox DT formulation (Iron Chelator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02435212 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the granule format of Deferasirox been granted authorization by the Food and Drug Administration?

"In comparison to other medications, Deferasirox granule formulation is assigned a tentative score of 2 as it has been trialled in Phase 2 trials and there exists some evidence indicating its safety but no data corroborating efficacy."

Answered by AI

Is the age limit for this clinical trial greater than fifty years?

"This study is enrolling individuals aged between 2 and 17 years."

Answered by AI

Are there numerous health care facilities conducting this investigation in North America?

"Patients can receive treatment at Children's Hospital Oakland Onc Dept in Oakland, California, Northwestern University Onc Dept in Memphis, Tennessee, St. Jude Children's Research Hospital Memphis St Jude in Philadelphia and 9 other medical sites across the US."

Answered by AI

Is this an innovative research endeavor?

"Since 2015, Deferasirox granule formulation has been progressively studied and developed. Initially sponsored by Novartis Pharmaceuticals, the initial trial in 2015 involved a total of 224 patients. Following this investigation, Phase 2 drug approval was granted to the compound. At present there are 3 ongoing trials for Deferasirox granule formulation spanning 21 countries with 20 distinct medical centres offering participation opportunities."

Answered by AI

What past research has been done on the efficacy of Deferasirox granule formulation?

"The initial investigation into the deferasirox granule formulation took place in 2015 at Lurie Children's Hospital of Chicago Oncology Department. To date, there are 57 trials that have concluded and 3 active studies conducted mainly out of Oakland, California."

Answered by AI

How many volunteers have been recruited to participate in this medical study?

"This trial has already concluded the recruitment of participants, as it was last modified on June 29th 2022. However, 12 studies concerning anemia are currently in need of volunteers and 3 trials for Deferasirox granule formulation still require enrolment."

Answered by AI

Is this research venture currently accepting subjects?

"This clinical trial is currently not enrolling patients. In terms of other studies, 12 trials are recruiting for anemia and 3 research programmes are actively seeking participants for Deferasirox granule formulation testing. It was initially posted on October 21st 2015 with its most recent update being June 29th 2022."

Answered by AI

What is the purpose of this research endeavor?

"Novartis Pharmaceuticals, which is sponsoring this trial, has determined that the primary outcome measure to be monitored over a 24-week period pertains to Change in serum ferritin among new ICT patients. Additionally, secondary efficacy metrics will comprise of gauging Compliance (using stick/pack tablet count), measuring Change in serum ferritin amongst new ICT patients and Domain scores of treatment satisfaction and palatability overtime using Patient / Observer Reported Outcomes (PRO/ObsRO)."

Answered by AI

May I be considered for participation in this medical research?

"This clinical trial, which has the capacity to accept 224 participants, is seeking patients between 2 and 17 years old who have anemia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload
2015. "Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02435212.
~24 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top