Combo Chelation Trial
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ClinicalTrials.gov Identifier: NCT00901199 |
Recruitment Status :
Completed
First Posted : May 13, 2009
Last Update Posted : August 7, 2013
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Condition or disease | Intervention/treatment | Phase |
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Thalassemia Iron Overload | Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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Child Cohort
This is the cohort in the study for children ages 8-18 years old. All subjects in this arm must have Liver Iron by SQUID of between 5-15mg/g dry liver and have a documented endocrinopathy or cardiac finding (low T2* or decreased cardiac function). All subjects in this arm will receive 7 days per week of Exjade and 3-5 days per week of Desferal.
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Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
All subjects will be given Exjade 7 days per week 20-30mg/kg and Deferoxamine 3-7 days per week 50mg/kg. Days per week are dependent on how much iron overload subject has.
Other Names:
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Moderate Adult Cohort
Adults in this arm will have moderate iron overload,defined as SQUID of 5-15mg/g dry weight. They will also have to have a documented endocrinopathy or cardiac finding (low T2*). All subjects in this cohort will receive 7 days per week of Exjade (20-30mg/kg) and Desferal (50mg/kg)3-5 days per week.
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Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
All subjects will be given Exjade 7 days per week 20-30mg/kg and Deferoxamine 3-7 days per week 50mg/kg. Days per week are dependent on how much iron overload subject has.
Other Names:
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Adults cohort with high iron overload
Adults with high iron overload defined as over 15mg/g dry liver. No cardiac finding or endocrinopathy necessary. Subjects in this cohort will receive Exjade 20-30mg/kg 7 days per week and Desferal (50mg/kg)5-7 days per week.
|
Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
All subjects will be given Exjade 7 days per week 20-30mg/kg and Deferoxamine 3-7 days per week 50mg/kg. Days per week are dependent on how much iron overload subject has.
Other Names:
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- Monitoring kidney function with urine protein/creatine levels [ Time Frame: with transfusion ]

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Ages Eligible for Study: | 8 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Transfusion Dependent Thalassemia
- If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented endocrinopathy or cardiac finding
- Older than 8 years
Exclusion Criteria:
- Participating on another interventional clinical trial

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 | |
CHRCO | |
Oakland, California, United States, 94609 |
Responsible Party: | Elliott Vichinsky, Director, Hematology/Oncology, UCSF Benioff Children's Hospital Oakland |
ClinicalTrials.gov Identifier: | NCT00901199 |
Other Study ID Numbers: |
CICL670AUS24T |
First Posted: | May 13, 2009 Key Record Dates |
Last Update Posted: | August 7, 2013 |
Last Verified: | August 2013 |
Thalassemia Chelation Iron Overload Thalassemia patients with Iron overload |
Thalassemia Iron Overload Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Iron Metabolism Disorders |
Metabolic Diseases Deferasirox Deferoxamine Iron Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Siderophores |