Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study

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Novartis

Status and phase

Completed
Phase 3
Phase 2

Conditions

Liver Iron Overload

Treatments

Drug: Deferasirox

Study type

Interventional

Funder types

Industry

Identifiers

NCT01033747
CICL670A0105E2

Details and patient eligibility

About

The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients Currently participating in the 9-month comparative prolongation of extension phase of the original study.
  • Patients currently participating in the food-effect sub-study, according to amendment 3.
  • Ability to provide written informed consent prior to participation in this non-comparative extension study.
  • Female patients sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
  • Body weight of at least 35 kg.

Exclusion criteria

  • Pregnant or breastfeeding patients.
  • History of non-compliance to medical regimens and patients who are considered potentially unreliable.
  • Proteinuria > 300 mg/L second void morning urine.
  • Patients with serum creatinine above the upper limit normal.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Deferasirox
Experimental group
Description:
Deferasirox group consists of all participants who were initially randomized to 10 and 20 mg/kg/day deferasirox orally daily in the main study and remained on the same treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative study
Treatment:
Drug: Deferasirox
Deferasirox Crossover
Experimental group
Description:
Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5mg/kg/day to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
Treatment:
Drug: Deferasirox

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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