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Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients

NCT00110617 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2011-05-26

Study results available
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Summary

This study will examine the long-term safety and efficacy of Deferasirox in patients with sickle cell disease and iron overload from repeated blood transfusions.

Conditions

Interventions

DRUG

Deferasirox (ICL670)

Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day.

DRUG

Deferoxamine (DFO)

Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases
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 NCT00110617 on ClinicalTrials.gov