At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 185 enrolled
Drug / intervention
ICL670drug
Likely dose
ICL670 40 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A One Year Open Label, Non-comparative Extension to a Randomized, Multicenter, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration (LIC) of Repeated Doses of 5-30mg/kg/Day ICL670 Relative to Deferoxamine (DFO) in Sickle Cell Disease (SCD) Patients With Transfusional Hemosideresis (THS) [Amendment 3: Extension Prolonged to 4-years]
In Brief
A Phase 2 clinical trial evaluating ICL670 for Sickle Cell Disease. Completed, enrolled 185 participants across 39 sites in 5 countries.
Detailed Summary
The safety, tolerability, effects on liver iron concentration and pharmacokinetics of ICL670 is studied in sickle cell disease patients with transfusional hemosiderosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesCanada, France, Italy, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2004
Primary CompletionJul 2009
First PostedMar 2010
TodayJul 2026
First PostedMar 19, 2010
Enrollment StartJul 1, 2004
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 16.3 years ago
Interventions
ICL670drug
Daily doses of ICL670 were taken orally 30 minutes before breakfast. The doses range from 5-40 mg/kg and were determined based on the patient's trend in serum ferritin over time during the core study (0109) and on the frequency of blood transfusions the patient received. The treatment duration was up to 4 years.