Completed

Combination Iron Chelation Therapy

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What is being tested

Combination Iron Chelation Therapy

Drug
Who is being recruted

Anemia+10

+ Anemia, Hemolytic

+ Anemia, Hemolytic, Congenital

Over 7 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 1998
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: January 14, 2010
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1998

Actual date on which the first participant was enrolled.

Patients with beta-thalassemia (Cooley's Anemia) continue to suffer from the transfusion-induced iron overload due to the inadequacies of current iron-chelation therapy. Compliance with the use of the only FDA-approved drug for removing excess iron from patients (Desferal) continues to be a major problem despite convincing evidence that it markedly reduces morbidity and prolongs life. The full potential of iron-chelation therapy will not be realized until an orally-effective drug is available. This small trial is testing the premise that a combination of drugs as a new approach to iron chelation therapy may reduce side effects and increase efficacy. If both drugs can be given orally, there may be a better chance of finding a suitable alternative to Desferal. Several combinations of experimental iron chelating drugs are being used in this trial.

NCT00004982NCT00004536
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: January 14, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 7 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaAnemia, HemolyticAnemia, Hemolytic, CongenitalHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesMetabolic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesIron Metabolism DisordersGenetic Diseases, InbornThalassemiaIron Overload

Criteria

1 inclusion criteria required to participate
Iron overload

1 exclusion criteria prevent from participating
Overt cardiac disease

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cornell University Medical College

New York, United StatesOpen Cornell University Medical College in Google Maps
CompletedOne Study Center