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Completed

NCT Number: NCT00733811

Efficacy Study of the Use of Sequential DFP-DFO Versus DFP

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.

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Key information

Conditions

Beta-Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia Thalassemia Major

Age range

13 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ao V. Cervello

Palermo, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deferiprone (DFP) and Deferoxamine (DFO)

Drug

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)

Deferiprone (DFP)

Drug

DFP alone at 75 mg/kg divided into three oral daily doses

Other names: DFP (Apotex, Canada)

Primary outcomes

  1. difference between multiple observations of the serum ferritin concentrations

    Time frame: five-year treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera V. Cervello

Other

Registry information

Official study title

Phase IV Study of the Use of Sequential DFP-DFO Versus DFP in Thalassemia Major Patients

Acronym: SEQDFPDFO

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2008
Registry last updated
Aug 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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