- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00069862
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
March 4, 2015 updated by: Genzyme, a Sanofi Company
A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
25
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10021
- The New York Presbyterian Hospital-Weill Medical College of Cornell University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Beta-thalassemia patients, 18 years of age or older, currently undergoing chronic blood transfusion therapy and iron chelation therapy who weigh more than 40 kg.
- No clinically significant findings on physical exam, medical history, or screening laboratories.
- Serum ferritin greater than 500 ng/mL, serum creatine creatinine within the normal range and platelet count greater than 100,000/mm3.
- Willing and able to discontinue DFO or L1 for the period of study.
- Woman of child-bearing potential must have a negative serum pregnancy test at screening and use a medically acceptable form of birth control during the study and for 1 month afterward. Male patients must also use barrier contraceptives during the study and for 1 month afterward.
- Have a level of understanding and willingness to cooperate with the confinement and all procedures. Able to provide voluntary signed/dated written informed consent.
Exclusion Criteria:
- Serious medical condition unrelated to Beta-Thalassemia.
- Participation in a previous investigational drug study within 30 days preceding screening.
- Patients with a known allergy to DFO that prevents chronic administration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
safety and tolerability
|
iron excretion in urine and stool
|
pharmacokinetic measurements
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
October 2, 2003
First Submitted That Met QC Criteria
October 2, 2003
First Posted (Estimate)
October 3, 2003
Study Record Updates
Last Update Posted (Estimate)
March 5, 2015
Last Update Submitted That Met QC Criteria
March 4, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GTC-134-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Beta-Thalassemia
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M.D. Anderson Cancer CenterWithdrawnSickle Cell Disease | Sickle Beta Thalassemia | Beta Thalassemia Major | Sickle Cell-SS Disease | Sickle Beta 0 Thalassemia | Sickle Beta Plus ThalassemiaUnited States
-
CelgeneTerminatedBeta Thalassemia Intermedia | Beta Thalassemia MajorFrance, United Kingdom, Italy, Greece
-
University of British ColumbiaCompletedSickle Cell Disease | Beta-Thalassemia | Sickle Cell Trait | Sickle Cell-Beta Thalassemia | Sickle Cell-SS DiseaseCanada, Nepal
-
Editas Medicine, Inc.RecruitingHemoglobinopathies | Thalassemia Major | Thalassemia Intermedia | Transfusion Dependent Beta ThalassemiaUnited States, Canada
-
Ionis Pharmaceuticals, Inc.TerminatedBeta Thalassemia IntermediaAustralia, Thailand, Greece, Lebanon, Turkey
-
Agios Pharmaceuticals, Inc.Active, not recruitingTransfusion-dependent Alpha-Thalassemia | Transfusion-dependent Beta-ThalassemiaSpain, Taiwan, Thailand, United States, France, Canada, Malaysia, Germany, Netherlands, Bulgaria, United Kingdom, Turkey, Italy, Greece, United Arab Emirates, Brazil, Denmark, Lebanon, Saudi Arabia
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Agios Pharmaceuticals, Inc.Active, not recruitingNon-Transfusion-dependent Alpha-Thalassemia | Non-Transfusion-dependent Beta-ThalassemiaSpain, Taiwan, Thailand, United Kingdom, Malaysia, United States, Netherlands, Bulgaria, Turkey, Italy, Canada, Brazil, France, United Arab Emirates, Denmark, Greece, Lebanon, Saudi Arabia
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Vifor (International) Inc.Labcorp Corporation of America Holdings, IncCompletedBeta-Thalassemia | Non-transfusion-dependent ThalassemiaGreece, Israel, Italy, Lebanon, Thailand
-
Lantu BiopharmaNot yet recruitingBeta-Thalassemia
-
bluebird bioCenter for International Blood and Marrow Transplant ResearchRecruitingBeta-ThalassemiaUnited States
Clinical Trials on Deferitrin (GT56-252)
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A2A Pharmaceuticals Inc.RecruitingTriple Negative Breast Cancer | Endometrial Cancer | High Grade Serous Ovarian CancerUnited States
-
Arcutis Biotherapeutics, Inc.CompletedChronic Hand EczemaUnited States, Australia, Canada
-
Akros Pharma Inc.TerminatedStudy of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252Diabetes MellitusUnited States
-
Genmedica Therapeutics S.L.Simbec ResearchTerminatedHealthy | Type 2 Diabetes MellitusUnited Kingdom
-
Arcutis Biotherapeutics, Inc.TerminatedVitiligoUnited States
-
Hakan AlkanNot yet recruitingAnkylosing Spondylitis
-
Genmedica Therapeutics S.L.Simbec ResearchTerminated
-
Daping Hospital and the Research Institute of Surgery...UnknownCervical Cancer | ComplicationsChina
-
Tung Wah CollegeCompleted