Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
ApoPharma |
---|---|
Information provided by: | ApoPharma |
ClinicalTrials.gov Identifier: | NCT00105495 |
The purpose of this study is to determine whether deferiprone has superior efficacy in removing excess iron from the heart when compared with deferoxamine.
Condition | Intervention | Phase |
---|---|---|
Thalassemia Major Hemosiderosis |
Drug: Ferriprox (deferiprone) Drug: Desferal (deferoxamine) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial Comparing the Relative Efficacy of Deferiprone to That of Deferoxamine in Removing Excess Cardiac Iron in Thalassemia Major Patients |
Estimated Enrollment: | 60 |
Study Start Date: | December 2002 |
Estimated Study Completion Date: | October 2004 |
This study is a multi-center, randomized, open-label, controlled clinical trial. The study population is participants with thalassemia major who are receiving regular chelation therapy with deferoxamine. A total of sixty (60) participants will be enrolled among the investigative sites.
The primary objective of this study is to determine whether deferiprone exhibits superior efficacy in removing excess iron from the heart compared to that of the standard therapy, deferoxamine. The secondary objective is to evaluate the relative efficacy of deferiprone with respect to that of deferoxamine as assessed by serum ferritin concentration and liver iron concentration. The primary efficacy measure in this study will be the participants' cardiac iron status, as determined by heart MRI T2* assessments.
The secondary efficacy measure will be by serum ferritin concentration and liver iron concentration. This will be measured by the Superconducting Quantum-Interference Device (SQUID) BioSusceptometer. The duration of treatment is 12 months.
Ages Eligible for Study: | 18 Years to 36 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Receiving ongoing chelation therapy with deferoxamine for at least the past five years. Those who have been exposed to deferiprone for
Exclusion Criteria:
Greece | |
Aghia Sophia Children's Hospital | |
Athens, Greece, 11527 | |
1st Department of Pediatrics, Athens University, Aghia Sophia Children's Hospital | |
Athens, Greece, 11527 | |
Italy | |
Dipartimento di Scienze e Dell' Adolescenza, University of Turin | |
Turin, Italy, 10126 | |
Italy, Sardegna | |
Ospedale Regionale Microcitemie, Dipartimento di Scienze | |
Cagliari, Sardegna, Italy, 09100 |
Principal Investigator: | Renzo Galanello, M.D. | Ospedale Regionale Microcitemie, Cagliari, Italy |
Principal Investigator: | Antonio Piga, M.D. | Dipartimento di Scienze Pediatriche e Dell'Adolescenza, University of Turin, Turin, Italy |
Principal Investigator: | Markissia Karagiorga, M.D. | Aghia Sophia Children's Hospital, Athens, Greece |
Principal Investigator: | Vassilis Ladis, M.D. | 1st Department of Pediatrics, Athens University, Aghia Sophia Children's Hospital, Athens, Greece |
Study ID Numbers: | LA16-0102 |
Study First Received: | March 15, 2005 |
Last Updated: | March 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00105495 History of Changes |
Health Authority: | European Union: European Medicines Agency |
Iron Overload Thalassemia Haemosiderosis |
Cardiac Deferiprone Chelation |
Metabolic Diseases Hematologic Diseases Deferiprone Beta-thalassemia Anemia Anemia, Hemolytic Iron Metabolism Disorders Thalassemia Anemia, Hemolytic, Congenital Thalassemia Minor |
Genetic Diseases, Inborn Hemosiderosis Beta-Thalassemia Hemoglobinopathies Chelating Agents Iron Overload Hemoglobinopathy Iron Metabolic Disorder Deferoxamine |
Metabolic Diseases Molecular Mechanisms of Pharmacological Action Hematologic Diseases Deferiprone Iron Chelating Agents Anemia Anemia, Hemolytic Iron Metabolism Disorders Thalassemia Pharmacologic Actions |
Siderophores Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hemosiderosis Beta-Thalassemia Hemoglobinopathies Chelating Agents Iron Overload Deferoxamine |