CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,683 enrolled
Drug / intervention
Deferasiroxdrug
Likely dose
Deferasirox 125–500 mg (calculated based on body weight), tablets dispersed in water or juice, taken orally once dailyAI-extracted
Key inclusion· 5
  • ✓Age ≥2 years
  • ✓Confirmed congenital disorder of red blood cells (thalassemia major, sickle cell anemia, diamond-blackfan anemia) requiring ongoing blood transfusions
  • ✓Cannot be adequately treated with locally approved iron chelator due to documented non-compliance (<50% doses in 12 months), contraindications, unacceptable toxicity, or poor response despite compliance
  • ✓History of at least 20 blood transfusions (≥100 mL/kg of packed red blood cells)
Key exclusion· 8
  • ✕Ongoing treatment with another iron chelator (any other must be discontinued ≥24 hours prior to study entry)
  • ✕Eligible for or with geographic access to other ongoing Novartis deferasirox clinical trials
  • ✕Unable to tolerate or have unacceptable toxicities from prior deferasirox treatment
  • ✕Serum creatinine above upper limit of normal at screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00235391
NCT00235391Phase 3Completed
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A Study to Provide Expanded Access of (Exjade®) Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload From Blood Transfusions Who Cannot Adequately be Treated With Other Locally Approved Iron Chelators

Novartis Pharmaceuticals·interventional·Posted Oct 10, 2005·Updated Jun 7, 2011

In Brief

A Phase 3 clinical trial evaluating Deferasirox for Thalassemia and 3 related conditions. Completed, enrolled 1,683 participants across 141 sites in 12 countries.

Detailed Summary

This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThalassemia, Sickle Cell Disease, Diamond Blackfan Anemia, Myelofibrosis
CountriesBelgium, Canada, Germany, Greece, Italy, Netherlands, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 10, 2005
Enrollment StartOct 1, 2005
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.7 years ago

Interventions

Deferasiroxdrug

125 mg, 250 mg and 500 mg tablets. Dosage was calculated based on participant's body weight. Tablets were dispersed in water, orange or apple juice and taken orally once a day.