CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 212 enrolled
Drug / intervention
Deferasirox (ICL670) +1 moredrug
Likely dose
Deferasirox 20 mg/kg/day orally (primary experimental arm)AI-extracted
Key inclusion· 6
  • ✓Age ≥2 years
  • ✓Diagnosed sickle cell disease (SS, SC, SD, Sβo or Sβ+ thalassemia)
  • ✓Iron overload documented by transfusion history (adults ≥120 ml/kg or 30 units; pediatric ≥120 ml/kg), ≥20 exchange transfusions, or liver iron ≥7 mg Fe/g by biopsy/MRI within 3 months
  • ✓Serum ferritin ≥1000 µg/mL on at least two occasions in prior year, measured without concurrent infection
Key exclusion· 13
  • ✕Serum creatinine above upper limit of normal
  • ✕Significant proteinuria or history of nephrotic syndrome
  • ✕ALT ≥250 U/L at screening
  • ✕Active hepatitis B or C, or history of HIV

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

Search/NCT00110617
NCT00110617Phase 2Completed
CompareCT.gov

A Randomized, Open-label, Multi-center, Phase II Study to Evaluate the Safety and Efficacy of Deferasirox (ICL670) 20 mg/kg/Day Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients With Iron Overload From Repeated Blood Transfusions

Novartis Pharmaceuticals·interventional·Posted May 11, 2005·Updated May 26, 2011

In Brief

A Phase 2 clinical trial evaluating Deferasirox (ICL670) and Deferoxamine (DFO) for Sickle Cell Disease and 2 related conditions. Completed, enrolled 212 participants across 59 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease, Iron Overload, Hemolytic Anemia
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 11, 2005
Enrollment StartMay 1, 2005
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 21.1 years ago

Interventions

Deferasirox (ICL670)drug

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.

Deferoxamine (DFO)drug

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