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

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera V. Cervello
ClinicalTrials.gov Identifier:
NCT00733811
First received: August 11, 2008
Last updated: August 12, 2008
Last verified: July 2008
History of Changes

August 11, 2008
August 12, 2008
September 2000
January 2008   (final data collection date for primary outcome measure)
difference between multiple observations of the serum ferritin concentrations [ Time Frame: five-year treatment ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of the Use of Sequential DFP-DFO Versus DFP
Phase IV Study of the Use of Sequential DFP-DFO Versus DFP in Thalassemia Major Patients

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.
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Beta-Thalassemia
  • Thalassemia Major
  • 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)
  • Drug: Deferiprone (DFP)
    DFP alone at 75 mg/kg divided into three oral daily doses
    Other Name: DFP (Apotex, Canada)
  • 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
    Intervention: Drug: Deferiprone (DFP) and Deferoxamine (DFO)
  • Active Comparator: 2
    Deferiprone alone at 75 mg/kg divided into three oral daily doses
    Intervention: Drug: Deferiprone (DFP)
Maggio A, Vitrano A, Capra M, Cuccia L, Gagliardotto F, Filosa A, Romeo MA, Magnano C, Caruso V, Argento C, Gerardi C, Campisi S, Violi P, Malizia R, Cianciulli P, Rizzo M, D'Ascola DG, Quota A, Prossomariti L, Fidone C, Rigano P, Pepe A, D'Amico G, Morabito A, Gluud C. Long-term sequential deferiprone-deferoxamine versus deferiprone alone for thalassaemia major patients: a randomized clinical trial. Br J Haematol. 2009 Apr;145(2):245-54. doi: 10.1111/j.1365-2141.2009.07609.x. Epub 2009 Feb 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
213
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
13 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00733811
AOVCervello
Yes
Not Provided
Not Provided
Aurelio Maggio, AO V Cervello
Azienda Ospedaliera V. Cervello
Not Provided
Study Chair: AURELIO MAGGIO, M.D. Azienda Ospedaliera V. Cervello
Azienda Ospedaliera V. Cervello
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP