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Completed

NCT Number: NCT00901199

Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload

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.

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHRCO

Oakland, California, 94609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)

Drug

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: Deferasirox, (Exjade), Deferoxamine (DFO)

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Elliott Vichinsky

Other

Registry information

Official study title

Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
May 13, 2009
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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