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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-16

Study Completion Date

2019-07-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Iron Overload

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Deferasirox

Intervention Type DRUG

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

Interventions

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Deferasirox

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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:

Exclusion Criteria

* 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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No