Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).
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|ClinicalTrials.gov Identifier: NCT01090323|
Recruitment Status : Completed
First Posted : March 19, 2010
Results First Posted : January 20, 2011
Last Update Posted : June 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Drug: ICL670||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||185 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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]|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||July 2009|
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.
- Number of Participants With Adverse Events After Start of ICL670 [ Time Frame: 0 - 60 months ]Safety as assessed by the number of participants with adverse event or death after the start of ICL670.
- Change in Serum Ferritin From Start of ICL670 to End of Study [ Time Frame: 0 - 60 months ]The main efficacy variable was change in serum ferritin in response to therapy with ICL670. Due to variability of serum ferritin, end of study was considered as the mean of at most the last 3 available observations after the start of ICL670.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090323
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|