Extend evaluation of deferasirox film-coated tablet (FCT) formulation
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria for subjects:
* Completed 24-weeks of study treatment as described in the core protocol (CICL670F2201).
* Were deemed to have tolerated deferasirox treatment by the investigator.
* Provided written informed consent/assent before any study-specific procedures were performed. For pediatric patients, consent was obtained from parent(s) or legal patient's representative. Investigators were to have also obtained assent of patients according to local, regional or national guidelines.
Key Exclusion for subjects:
The exclusion criteria followed those described for the core protocol CICl670F2201, which were as follows:
* Creatinine clearance below the contraindication limit in the locally approved prescribing information.
* Serum creatinine \> 1.5 × upper limit of normal range (ULN) at Screening
* Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \> 5 × ULN,
* Significant proteinuria
* Patients with significant impaired gastrointestinal function or gastrointestinal disease
* Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
* Patients with psychiatric or addictive disorders
* Patients with a known history of HIV seropositivity (Elisa or Western blot).
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was an evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
* Patients with a history of hypersensit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overview of Number of Participants With Adverse Events
Timeframe: Baseline up to approximately 25 months
2
Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12
Timeframe: Baseline, 6 and 12 months
3
Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12
Timeframe: Baseline, 6 and 12 months
4
Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12
Timeframe: Baseline, 6 and 12 months
5
Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12
Timeframe: Baseline, 6 and 12 months
6
Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12
Timeframe: Baseline, 6 and 12 months
7
Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12