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Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients

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ClinicalTrials.gov Identifier: NCT00350662
Recruitment Status : Completed
First Posted : July 11, 2006
Last Update Posted : November 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Comparison of efficacy and toxicity of the combination treatment of deferiprone and desferrioxamine with the single agent treatment of either drug

Condition or disease Intervention/treatment Phase
Hemochromatosis Drug: Deferiprone (L1) Drug: Desferrioxamine Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Open-label Phase III Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients
Study Start Date : January 2002


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Clinical efficacy (Iron balance and liver iron concentration) [ Time Frame: At baseline and at 12 months ]

Secondary Outcome Measures :
  1. Safety profile (general, hematologic, and organ toxicity) [ Time Frame: At 3-monthly intervals ]
  2. Liver histology [ Time Frame: At baseline and at 12 months ]
  3. Quality of life (patient's subjective of compliance and tolerance) [ Time Frame: At 3-monthly intervals ]
  4. Actual treatment duration (ATD) [ Time Frame: At 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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
First Posted: July 11, 2006    Key Record Dates
Last Update Posted: November 19, 2012
Last Verified: November 2012

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
Deferiprone
Deferoxamine
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Siderophores