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Also known as Deferasirox dispersable tablet (DT)
Deferasirox dispersable · 1 trial · 2 indications
Number of participants preferring deferasirox FCT or DT as measured by preference questionnaire (item 2) at Week 48. The preference questionnaire was a 3-item questionnaire. At Week 48, the second item of the preference questionnaire asked the patients (or parents of young patients from 2 to 9 years old) which medicine did the patient "like best": "Tablet to dissolve in liquid" (=deferasirox DT), "Film coated tablet" (=deferasirox FCT), "Sprinkle powder on food" (=deferasirox FCT) and "I don't know" (=none of the above). The number of participants who selected each response option for item 2 was assessed. The analysis was performed for participants who answered the item 2 of the preference questionnaire.
| Arm | Type | Description |
|---|---|---|
| Deferasirox DT followed by deferasirox FCT | EXPERIMENTAL | Participants were treated with deferasirox DT followed by deferasirox FCT (core phase). Those who entered the extension phase were treated with deferasirox FCT |
| Name | Type | Description |
|---|---|---|
| Deferasirox dispersable tablet (DT) | DRUG | Deferasirox DT was provided as 125 mg, 250 mg, 500 mg dispersible tablets for oral use. The strengths provided in an individual country could differ and reflected the strengths available commercially in each country. For iron chelation naive participants, the starting dose on Baseline Day 1 was 20 mg/kg/day in TDT and 10 mg/kg/day in NTDT. For iron chelation (deferoxamine and/or deferiprone) pre-treated participants, the starting dose was equivalent to the dose of deferoxamine received (for participants pre-treated with deferoxamine) and based on their serum ferritin levels (for participants pre-treated with deferiprone). Participants took deferasirox DT once daily for 24 weeks (core phase). The required number of deferasirox DT tablets were to be dispersed with gentle stirring in a glass of water. |
| Deferasirox film coated tablet (FCT) | DRUG | Deferasirox FCT was provided as 90 mg, 180 mg, 360 mg film coated tablets for oral use. The FCT starting dose on Week 25 was 14 mg/kg/day in TDT and 7 mg/kg/day in NTDT. Participants took deferasirox FCT once daily for 24 weeks during the core phase and up to 48 weeks during the extension phase. For patients with difficulties in swallowing deferasirox FCT, it was allowed to crush the film-coated tablets and administer the study drug by sprinkling the full dose on soft food (like yogurt or apple puree). |
Inclusion Criteria: 1. Prior to any screening procedures were performed, written informed consent/assent must be provided. For pediatric patients, consent was obtained from parent(s) or legal patient's representative. Investigators also obtained assent of patients according to local, regional or na...
Deferasirox dispersable is an oral iron chelation therapy used in patients with transfusion-dependent thalassemia to manage chronic iron overload from repeated blood transfusions. It is a dispersible tablet formulation designed to be mixed in liquid before swallowing, which supports use in patients who have difficulty taking film-coated tablets.
Deferasirox dispersable is developed and manufactured by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this dispersible tablet formulation in patients with thalassemia.
Deferasirox dispersable has been studied in a Phase 2 clinical trial. It is an investigational formulation in this development program and is not described as FDA approved for this use based on the available program information.
Deferasirox dispersable has been evaluated in one completed Phase 2 trial, NCT02993224, titled an open-label, multicenter study assessing preference for deferasirox film-coated tablet compared to dispersible tablet. The trial enrolled 148 patients across Egypt, Lebanon, Morocco, Saudi Arabia, Thailand, Turkey, and Vietnam, and included patients with transfusion-dependent and non-transfusion-dependent thalassemia.
Yes. Deferasirox dispersable is also known as Deferasirox dispersable tablet, often abbreviated as DT. Both names refer to the same dispersible tablet formulation of deferasirox developed by Novartis for oral iron chelation in thalassemia patients.
Deferasirox dispersable is a small molecule iron chelator. It binds excess iron in the body to form a complex that is excreted, thereby reducing iron overload in patients receiving chronic transfusions. This mechanism supports its use in transfusion-dependent thalassemia, where repeated transfusions lead to iron accumulation.