Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation

Phase 3

Completed

• Conditions: Chronic Iron Overload
• Interventions: Drug: Deferasirox

• Registration Number: NCT02720536
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Extend evaluation of deferasirox film-coated tablet (FCT) formulation

Detailed Description

Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients who had completed study CICL670F2201

* Provide patients who completed 24 weeks of treatment in the core study, CICL670F2201, the possibility to have additional treatment with the deferasirox FCT.

* Collect additional longer term data on the safety and the tolerability of the deferasirox FCT.

* Collect efficacy data on the deferasirox FCT in reduction or maintenance of iron burden as measured by serum ferritin level.

Study Timeline

• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-28
• Study Start: 2016-08-16
• Primary Completion: 2019-07-23
• Study Completion: 2019-07-23
• Results First Submitted: 2020-01-22
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Results First Posted: 2020-03-03
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deferasirox	Deferasirox	Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.

Primary Outcome Measures

Name	Time	Method
Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12	Baseline, 6 and 12 months	The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12	Baseline, 6 and 12 months	The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12	Baseline, 6 and 12 months	The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12	Baseline, 6 and 12 months	The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12	Baseline, 6 and 12 months	The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12	Baseline, 6 and 12 months	The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline
Overview of Number of Participants With Adverse Events	Baseline up to approximately 25 months	Numbers represent counts of participants within the categories. An adverse event (AE) was defined as treatment emergent if its onset date is on or after (≥) the first administration of study treatment within this study or events present prior to start of study treatment but increased in severity on or after (≥) the first administration of study treatment within this study but not later than 30 days after the last study treatment in this study
Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12	Baseline, 6 and 12 months	The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline

Secondary Outcome Measures

Name	Time	Method
Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12	Baseline, 6 and 12 months	The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline. A negative change from baseline is regarded as an improvement in this study
Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12	Baseline, 6 and 12 months	The percentage relative change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Percentage relative change = 100 × (\[Post - Baseline\] / Baseline). Percentage relative change is calculated for each patient individually and then overall descriptive summary statistics is obtained for subjects with a value at baseline and the particular time point. A negative percentage relative change from baseline is regarded as an improvement in this study

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Napoli, Italy