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| Sponsored by: |
Azienda Ospedaliera V. Cervello |
|---|---|
| Information provided by: | Azienda Ospedaliera V. Cervello |
| ClinicalTrials.gov Identifier: | NCT00733811 |
Purpose
Changes in chelation treatment and transfusion practices, during the past two decades, have dramatically improved the prognosis of thalassemia major patients.Deferiprone (DFP) has been compared with deferoxamine (DFO), using different schedules of treatment, in the majority of the 13 clinical trials published between 1990 and 2008.No statistically significant difference was shown between these two interventions during, at most, 18 months of treatment.Three randomised trials that compared sequential DFP-DFO treatment versus DFO alone reported controversial results but this could be due to small sample sizes and short treatment duration. In fact, no trial with treatment duration longer than 18 months15, which reported on mortality, adverse events, serum ferritin concentrations, as well as costs has so far been published.
This long-term sequential DFP-DFO treatment versus DFP alone treatment trial was conducted to assess the impacts of these chelation treatments on serum ferritin concentrations, mortality, adverse events, and costs in thalassemia major patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Beta-Thalassemia Thalassemia Major |
Drug: Deferiprone (DFP) and Deferoxamine (DFO) Drug: Deferiprone (DFP) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase IV Study of the Use of Sequential DFP-DFO Versus DFP in Thalassemia Major Patients |
| Enrollment: | 213 |
| Study Start Date: | September 2000 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Sequential treatment including DFP at 75 mg/kg, divided into three oral daily doses, for four days per week and DFO by subcutaneous infusions (8-12h) at 50 mg/kg/day for the remaining three days per week
|
Drug: Deferiprone (DFP) and Deferoxamine (DFO)
Sequential treatment including DFP at 75 mg/kg for four days per week and DFO by subcutaneous infusions (8-12h) at 50mg/kg/day for the remaining three days per week
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2: Active Comparator
Deferiprone alone at 75 mg/kg divided into three oral daily doses
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Drug: Deferiprone (DFP)
DFP alone at 75 mg/kg divided into three oral daily doses
|
The trial was designed as a multicentre randomised open-label trial with blinded data management and data analyses, to assess whether either treatment was superior to the other. The trial was performed on behalf of the Italian Society for the study of Thalassemia and Haemoglobinopathies (SoSTE). The investigators initiated, carried out, and controlled the trial, which was conducted without influence of the non-commercial sponsor.16
Eligibility| Ages Eligible for Study: | 13 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | AO V Cervello ( Aurelio Maggio ) |
| Study ID Numbers: | AOVCervello, No |
| Study First Received: | August 11, 2008 |
| Last Updated: | August 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00733811 |
| Health Authority: | Italy: Ministry of Health |
|
thalassemia major chelation treatment secondary hemochromatosis |
|
Hematologic Diseases Isoflurophate Deferiprone Beta-thalassemia Anemia Anemia, Hemolytic Hemochromatosis, type 3 Thalassemia Anemia, Hemolytic, Congenital |
Thalassemia minor Genetic Diseases, Inborn Beta-Thalassemia Hemoglobinopathies Neoplasm Metastasis Hemochromatosis Hemoglobinopathy Iron Deferoxamine |
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Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Iron Chelating Agents Enzyme Inhibitors |
Chelating Agents Cholinergic Agents Pharmacologic Actions Protease Inhibitors Siderophores |
