drugset / Trial / NCT02993224

Open-label, Multicenter Study Assessing Preference for Deferasirox Film-coated Tablet Compared to Dispersible Tablet

NCT02993224 ↗

Phase 2 Completed 148 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelOther

Summary

Study to evaluate patient preference of deferasirox film-coated tablet (FCT) or deferasirox dispersible tablet (DT) in patient with transfusion - dependent thalassemia or non-transfusion -dependent thalassemia as measured by preference questionnaire at Week 48

Timeline

Start
2017-07-27
Primary completion
2020-01-29
Completion
2021-03-11

Outcome

Met primary endpoint

registry analysis (superiority test); Deferasirox DT Followed By Deferasirox FCT; p <.0001; Difference of proportion 0.83 (95% CI 0.75 to 0.89); McNemar NCT02993224 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferasirox Unknown 7 mg/kg Oral
Subject Deferasirox Unknown 10 mg/kg Oral
Subject Deferasirox Unknown 14 mg/kg Oral
Subject Deferasirox Unknown 20 mg/kg Oral