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
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Sponsor:
Elliott Vichinsky
Information provided by (Responsible Party):
Elliott Vichinsky, UCSF Benioff Children's Hospital Oakland
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Tracking Information | ||||
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First Submitted Date ICMJE | May 12, 2009 | |||
First Posted Date ICMJE | May 13, 2009 | |||
Results First Submitted Date ICMJE | June 14, 2021 | |||
Results First Posted Date ICMJE | August 12, 2021 | |||
Last Update Posted Date | August 12, 2021 | |||
Study Start Date ICMJE | September 2007 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Monitoring kidney function with urine protein/creatine levels [ Time Frame: with transfusion ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload | |||
Official Title ICMJE | Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload | |||
Brief Summary | This is a pilot study looking at the safety and efficacy of giving combination chelation with deferasirox and deferoxamine. The hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia. | |||
Detailed Description | This was a phase two pilot clinical trial designed to evaluate the safety and efficacy of the combination of deferasirox and deferoxamine in transfusion dependent thalassemia with a range of systemic iron burden. The duration of combined therapy was 12 months. Changes in liver iron concentration, ferritin, myocardial iron, and serum creatinine was monitored. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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.
Other Names:
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Study Arms ICMJE | Experimental: Deferasirox (Exjade) and Deferoxamine (DFO)
All subjects received Deferasirox (Exjade) and Deferoxamine (DFO) dosing based on the iron overload at baseline.
Intervention: Drug: Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)
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Publications * | Lal A, Porter J, Sweeters N, Ng V, Evans P, Neumayr L, Kurio G, Harmatz P, Vichinsky E. Combined chelation therapy with deferasirox and deferoxamine in thalassemia. Blood Cells Mol Dis. 2013 Feb;50(2):99-104. doi: 10.1016/j.bcmd.2012.10.006. Epub 2012 Nov 11. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
22 | |||
Original Estimated Enrollment ICMJE |
15 | |||
Actual Study Completion Date ICMJE | October 2012 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 8 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00901199 | |||
Other Study ID Numbers ICMJE | CICL670AUS24T | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Elliott Vichinsky, UCSF Benioff Children's Hospital Oakland | |||
Original Responsible Party | Elliott Vichinsky MD, Children's Hospital and Research Center Oakland | |||
Current Study Sponsor ICMJE | Elliott Vichinsky | |||
Original Study Sponsor ICMJE | UCSF Benioff Children's Hospital Oakland | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | UCSF Benioff Children's Hospital Oakland | |||
Verification Date | July 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |