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Safety and Efficacy of Deferasirox in Combination With Desferoxamine in β-thalassaemia Patients With Severe Cardiac Iron Overload

NCT01459718 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-10-23

Study results available
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Summary

The primary efficacy endpoint of this interventional study was to evaluate the number of patients achieving a complete response (CR), defined as patients switching from intensive deferasirox -DFO treatment, at any time point during the 24 months of study, to deferasirox monotherapy based on improvement in the cardiac magnetic resonance imaging (MRI) T2\* value to \>10ms, and continue to maintain their MRI T2\* to values \>10 msec.

Conditions

  • Transfusion-dependent β-thalassemia Patients
  • Cardiac Iron Overload

Interventions

DRUG

Deferasirox

20-40 mg/kg/day orally, once daily

DRUG

Deferoxamine (DFO)

40 mg/kg/day subcutaneous (sc) infusion, 3-4 days per week

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Greece

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01459718 on ClinicalTrials.gov