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Efficacy Study of the Use of Sequential DFP-DFO Versus DFP (SEQDFPDFO)

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ClinicalTrials.gov Identifier: NCT00733811
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : August 13, 2008
Sponsor:
Information provided by:
Azienda Ospedaliera V. Cervello

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Beta-Thalassemia Thalassemia Major Drug: Deferiprone (DFP) and Deferoxamine (DFO) Drug: Deferiprone (DFP) Phase 4

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Study of the Use of Sequential DFP-DFO Versus DFP in Thalassemia Major Patients
Study Start Date : September 2000
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia
Drug Information available for: Deferiprone

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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
Other Names:
  • DFP (Apotex, Canada)
  • DFO (Biofutura Pharma S.p.A.,Italy)
Active Comparator: 2
Deferiprone alone at 75 mg/kg divided into three oral daily doses
 Drug: Deferiprone (DFP)
DFP alone at 75 mg/kg divided into three oral daily doses
Other Name: DFP (Apotex, Canada)


Outcome Measures
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Primary Outcome Measures :
  1. difference between multiple observations of the serum ferritin concentrations [ Time Frame: five-year treatment ]

Secondary Outcome Measures :
  1. the difference between the T2* signal at magnetic resonance imaging (MRI) of heart and liver at T0 and T1 time (see below); survival analysis; adverse events; treatment failures; and costs. [ Time Frame: five years ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Thalassemia major patients with serum ferritin concentration between 800 to 3,000 ng/ml and were over 13 years of age

Exclusion Criteria:

  • Known intolerance to one of the trial treatments
  • Platelet count < 100,000/mm3 or or leukocyte count < 3,000/mm3
  • Severe liver damage indicated by ascites
  • Heart failure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733811


Locations
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Italy
Ao V. Cervello
Palermo, Italy
Sponsors and Collaborators
Azienda Ospedaliera V. Cervello
Investigators
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Study Chair: AURELIO MAGGIO, M.D. Azienda Ospedaliera V. Cervello
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aurelio Maggio, AO V Cervello
ClinicalTrials.gov Identifier: NCT00733811    
Other Study ID Numbers: AOVCervello
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: August 13, 2008
Last Verified: July 2008
Keywords provided by Azienda Ospedaliera V. Cervello:
thalassemia major
chelation treatment
secondary hemochromatosis
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
 Deferiprone
Deferoxamine
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Siderophores