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Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lipomed
ClinicalTrials.gov Identifier:
NCT00350662
First received: July 10, 2006
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

Comparison of efficacy and toxicity of the combination treatment of deferiprone and desferrioxamine with the single agent treatment of either drug


Condition Intervention Phase
Hemochromatosis
 Drug: Deferiprone (L1)
Drug: Desferrioxamine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Open-label Phase III Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients

Resource links provided by NLM:

MedlinePlus related topics: Hemochromatosis Iron
U.S. FDA Resources

Further study details as provided by Lipomed:

Primary Outcome Measures:
  • Clinical efficacy (Iron balance and liver iron concentration) [ Time Frame: At baseline and at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety profile (general, hematologic, and organ toxicity) [ Time Frame: At 3-monthly intervals ] [ Designated as safety issue: Yes ]
  • Liver histology [ Time Frame: At baseline and at 12 months ] [ Designated as safety issue: Yes ]
  • Quality of life (patient's subjective of compliance and tolerance) [ Time Frame: At 3-monthly intervals ] [ Designated as safety issue: No ]
  • Actual treatment duration (ATD) [ Time Frame: At 12 months ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: January 2002
Arms Assigned Interventions
Experimental: Deferiprone + Desferrioxamine Drug: Deferiprone (L1)
75 mg/kg body weight daily
Drug: Desferrioxamine
In combination with deferiprone: 40-50 mg/kg body weight 2-times weekly As single agent: 40-50 mg/kg body weight 5- to 7-times weekly
Experimental: Deferiprone single agent Drug: Deferiprone (L1)
75 mg/kg body weight daily
Active Comparator: Desferrioxamine single agent Drug: Desferrioxamine
In combination with deferiprone: 40-50 mg/kg body weight 2-times weekly As single agent: 40-50 mg/kg body weight 5- to 7-times weekly

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Iron-overloaded patients without prior iron chelation therapy as well as pretreated patients
  • Age: 4 years and older
  • Sex: male and female
  • Written informed consent

Exclusion Criteria:

  • Children < 4 years of age
  • Patients non-compliant to DFO or L1
  • Patients with known DFO or L1 toxicity/intolerance
  • Neutropenia (neutrophils < 1.5 x 10exp9/L)
  • Thrombocytopenia (platelets < 100 x 10exp9/L)
  • Renal, hepatic (liver enzymes 2.5x of upper normal level and higher) or decompensated heart failure
  • Active viral illness currently treated with interferon-alpha/ribavirin
  • Patients with repeated Yersinia infections
  • HIV-positivity
  • Pregnancy and nursing
  • Female and male of reproductive age planning for family, sexually active but not taking adequate contraceptive precaution
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350662

Locations
Egypt
Pediatric Hospital, Cairo University
Cairo, Egypt
Turkey
EGE University Medical School
Bornova, Izmir, Izmir, Turkey, 35100
Sponsors and Collaborators
Lipomed
Investigators
Principal Investigator: Amal M El-Beshlawy, Prof. Dr. Pediatric Hospital, Cairo University, Cairo, Egypt
Principal Investigator: Yesim Aydinok, Prof. Dr. EGE University Medical School Bornova, Izmir, Turkey
  More Information

Publications:

Responsible Party: Lipomed
ClinicalTrials.gov Identifier: NCT00350662     History of Changes
Other Study ID Numbers: DF-1
Study First Received: July 10, 2006
Last Updated: November 16, 2012
Health Authority: Turkey: Ethics Committee
Egypt: Institutional Review Board

Keywords provided by Lipomed:
Deferiprone
L1
Desferrioxamine
 Hemochromatosis
Iron overload
Thalassemia

Additional relevant MeSH terms:
Hemochromatosis
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
 Deferoxamine
Deferiprone
Siderophores
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013