Phase 3 N=70 Treatment

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

Liver Iron Overload

Bottom Line

View on ClinicalTrials.gov: NCT01033747 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

Aug 2011

Primary outcome: Primary: The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox — -21.9; -23.1 Percent change

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Deferasirox (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox	-21.9; -23.1	—
SECONDARY Relative Change in Serum Ferritin From Baseline to 3.5 Years	32.4; 33.2	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01033747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.