ClinicalTrials.gov
ClinicalTrials.gov Menu

Combo Chelation Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00901199
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Elliott Vichinsky, Children's Hospital & Research Center Oakland

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a small pilot study looking at the safety of giving combination chelation with Exjade and Desferal to 15 patients. The hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia.

Condition or disease Intervention/treatment Phase
Thalassemia Iron Overload Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO) Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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:
  • Exjade, ICL670 (deferisirox)
  • DFO, Desferal (deferoxamine)
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.
 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:
  • Exjade, ICL670 (deferisirox)
  • DFO, Desferal (deferoxamine)
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:
  • Exjade, ICL670 (deferisirox)
  • DFO, Desferal (deferoxamine)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Monitoring kidney function with urine protein/creatine levels [ Time Frame: with transfusion ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, California
CHRCO
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Elliott Vichinsky, Director, Hematology/Oncology, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT00901199     History of Changes
Other Study ID Numbers: CICL670AUS24T
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by Elliott Vichinsky, Children's Hospital & Research Center Oakland:
Thalassemia
Chelation
Iron Overload
Thalassemia patients with Iron overload

Additional relevant MeSH terms:
Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Iron
 Deferasirox
Deferoxamine
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Siderophores