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

Phase 3CompletedNCT02720536

Novartis Pharmaceuticals53 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Iron Overload

Interventions

DeferasiroxDRUG

Deferasirox FCT will be provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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 hypersensitivity to any of the study drug or excipients. * Patients with significant medical condition that could interfere with the ability to participate in this study * Patients who were participating in another clinical trial or receiving an investigational drug. * Patients using prohibited medication, * Patients with liver disease with severity of Child-Pugh Class B or C. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using effective methods of contraception during dosing of study treatment

Locations (14)

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Goudi-Athens, GR, Greece

Novartis Investigative Site

Pátrai, Greece

Outcomes

Primary Outcomes

Overview of Number of Participants With Adverse Events

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

Time frame: Baseline up to approximately 25 months

Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12

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

Time frame: Baseline, 6 and 12 months

Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12

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

Time frame: Baseline, 6 and 12 months

Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12

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

Time frame: Baseline, 6 and 12 months

Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12

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

Time frame: Baseline, 6 and 12 months

Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (14)

Outcomes

Primary Outcomes

Secondary Outcomes