Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
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|ClinicalTrials.gov Identifier: NCT00901199|
Recruitment Status : Completed
First Posted : May 13, 2009
Results First Posted : August 12, 2021
Last Update Posted : August 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Thalassemia Iron Overload||Drug: Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Deferasirox (Exjade) and Deferoxamine (DFO)
All subjects received Deferasirox (Exjade) and Deferoxamine (DFO) dosing based on the iron overload at baseline.
Drug: Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)
All subjects will be given Deferasirox 20-30 mg/kg for 7 days per week. All subject will be given Deferoxamine 50 mg/kg for 3-7 days per week. The number of days for Deferoxamine will be determined by liver iron concentration at baseline.
- Efficacy of Combined Treatment With Deferasirox and Deferoxamine Over 12 Months [ Time Frame: 12 months ]Change in liver iron concentration from baseline to 12 months with the use of combined chelation therapy. The change was calculated as the liver iron concentration at 12 months minus the value at baseline.
- Change in Serum Creatinine During 12 Months Combined Chelation Therapy [ Time Frame: 12 months ]Comparison of average serum creatinine over 12 months of combined chelation therapy compared with baseline serum creatinine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901199
|United States, California|
|Oakland, California, United States, 94609|
|Principal Investigator:||Elliot Vichinsky, MD||UCSF Benioff Children's Hospital Oakland|