NCT00004982

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1998

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2000

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

First QC Date

March 13, 2000

Last Update Submit

January 12, 2010

Conditions

Iron OverloadThalassemia

Keywords

chelation therapycombination chemotherapyiron poisoningthalassemiachelating agentdeferoxaminedrug screening /evaluationtherapy evaluation

Interventions

Combination Iron Chelation TherapyDRUG

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Iron overload

You may not qualify if:

  • Overt cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell University Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Iron OverloadThalassemia

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 13, 2000

First Posted

March 14, 2000

Study Start

December 1, 1998

Study Completion

November 1, 2002

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

US(1)