MedDataX Logo

Combination Iron Chelation Therapy

NCT ID: NCT00004982

Last Updated: 2010-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

1998-12-31

Study Completion Date

2002-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combination Deferasirox and Deferiprone for Severe Iron Overload in Thalassemia

NCT01709032

Thalassemia Major With Severe Transfusional Iron Overload
COMPLETED PHASE1/PHASE2

Evaluation of Subcutaneous Desferrioxamine as Treatment for Transfusional Hemochromatosis

NCT00000595

Anemia (Iron-Loading) Beta-Thalassemia Hematologic Diseases +4 more
COMPLETED PHASE2

Compassionate Use of Deferiprone for Patients With Thalassemia and Iron-Induced Heart Disease

NCT00293098

Iron Overload
APPROVED_FOR_MARKETING

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

NCT00901199

Thalassemia Iron Overload
COMPLETED PHASE2

Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Rare Chronic Anemia Patients

NCT00303329

Anemia Hemosiderosis
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Overload Thalassemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Combination Iron Chelation Therapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Iron overload

Exclusion Criteria

* Overt cardiac disease
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cornell University Medical College

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01DK055463-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHELATION (completed)

Identifier Type: -

Identifier Source: org_study_id

NCT00004536

Identifier Type: -

Identifier Source: nct_alias

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload
NCT00171210 COMPLETED PHASE3
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
NCT00069862 COMPLETED PHASE1/PHASE2
Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major
NCT00800761 COMPLETED PHASE4
Efficacy and Safety of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml)
NCT01996683 UNKNOWN NA
Hydroxyurea to Treat Beta-Thalassemia (Cooley's Anemia)
NCT00001958 COMPLETED PHASE2
Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload
NCT01186419 COMPLETED PHASE2
Safety and Pharmacokinetic Study of Escalating Multiple Doses of an Iron Chelator in Patients With Iron Overload
NCT01039636 COMPLETED PHASE1
Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox
NCT01905774 COMPLETED
Safety & Efficacy of ICL670 vs. Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood Transfusions
NCT00061750 COMPLETED PHASE3
Combined Chelation Treatment With Deferiprone and Deferoxamine in Thalassemia Major
NCT00103753 UNKNOWN PHASE4
Clinical Importance of Treating Iron Overload in Sickle Cell Disease
NCT00981370 TERMINATED PHASE3
Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone
NCT00000588 COMPLETED PHASE2
Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients
NCT05355766 COMPLETED PHASE2
Retrospective Evaluation of Adult and Pediatric Transfusion-dependent Patients Treated With Deferasirox Therapy
NCT01874405 COMPLETED
Deferoxamine for the Treatment of Hemochromatosis
NCT00001203 COMPLETED
Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic Anemias
NCT00061763 COMPLETED PHASE2
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
NCT00379483 COMPLETED PHASE2
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
NCT00390858 COMPLETED PHASE2
Combination Therapy Compared With Single-Drug Therapy in Patients With Cardiac Diseases
NCT00115349 TERMINATED PHASE2
A Study of Long-term Treatment With Deferasirox in Patients With Beta-thalassemia and Transfusional Hemosiderosis
NCT00171171 COMPLETED PHASE3
Clinical Trial of Deferasirox Combination Treatment With Deferiprone In Thalassaemia Patients
NCT02198508 COMPLETED NA
Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
NCT00110266 COMPLETED PHASE2
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
NCT00560820 COMPLETED PHASE1
Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
NCT00600938 COMPLETED PHASE2
Safety and Efficacy of Deferasirox in Combination With Desferoxamine in β-thalassaemia Patients With Severe Cardiac Iron Overload
NCT01459718 TERMINATED PHASE2