CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 176 enrolled
Drug / intervention
Deferasiroxdrug
Likely dose
Deferasirox 20 mg/kg/dayAI-extracted
Key inclusion· 7
  • ✓Low-risk or intermediate-1 (INT-1) risk MDS
  • ✓Age ≥18 years
  • ✓≥30 lifetime packed RBC transfusions
  • ✓Serum ferritin ≥1000 ng/mL on at least two occasions ≥2 weeks apart in prior year, and ≥1000 ng/mL at screening
Key exclusion· 11
  • ✕Serum creatinine above upper limit of normal
  • ✕ALT >500 U/L during screening
  • ✕Clinical or laboratory evidence of active Hepatitis B or C
  • ✕Urinary protein/creatinine ratio >0.5 mg/mg

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

Search/NCT00110266
NCT00110266Phase 2Completed
CompareCT.gov

An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-risk and INT-1, Myelodysplastic Patients Using Serum Ferritin Monitoring

Novartis Pharmaceuticals·interventional·Posted May 5, 2005·Updated Aug 16, 2021

In Brief

A Phase 2 clinical trial evaluating Deferasirox for Myelodysplastic Syndrome and Iron Overload. Completed, enrolled 176 participants across 48 sites in 2 countries.

Detailed Summary

The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome, Iron Overload
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2005
Enrollment StartJul 25, 2005
Primary CompletionMar 28, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 21.2 years ago

Interventions

Deferasiroxdrug

20 mg/kg/day over one year in patients with MDS