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Efficacy and Safety of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Mohsen Saleh Elalfy, Ain Shams University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996683
First Posted: November 27, 2013
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University
  Purpose
safety and efficacy of different iron chelation therapy in transfusion dependent beta-thalaasemia patients with low serum ferritin and continued regular transfusion regimen.

Condition Intervention
Beta-thalassemia Serum Ferritin Iron Chelation Therapy Drug: desferal, ferriprox, blood transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Prospective Comparative Study of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml)

Resource links provided by NLM:


Further study details as provided by Mohsen Saleh Elalfy, Ain Shams University:

Primary Outcome Measures:
  • downward-trend of SF(serum ferritin) over previous 6 months after reduction of chelation dose with continuation of regular transfusion regimen. [ Time Frame: 6 month ]
    non inferiority of discounting chelation compared with continuing chelation in thalassemia patients with low serum ferritin and/or showing a downward-trend of SF(serum ferritin) over previous 6 months after reduction of chelation dose with continuation of regular transfusion regimen.


Secondary Outcome Measures:
  • safety and occurrence of AEs in both studied groups (with and without chelation) in relation to different chelation therapy. [ Time Frame: 12 month ]
    determine the safety and occurrence of AEs in both studied groups (with and without chelation) in relation to different chelation therapy.


Estimated Enrollment: 50
Study Start Date: November 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: iron chelation
Included 25 thalassemia patients with low serum ferritin (< 500) or downward ferritin trend inspite of reduction of chelation dose over the last 6 months. They will continue their chelation therapy.
Drug: desferal, ferriprox, blood transfusion

Deferiprone (75-100 mg/kg/d) and deferoxamine (20-60 mg/kg/d) aimed at achieving "normal" body iron stores in poly-transfued arm1.

Arm 2 will only recieve blood transfusion with no chelation

Other Names:
  • deferiprone
  • deferoxamine
Placebo Comparator: blood transfusion only
Included 25 thalassemia patients with low serum ferritin (< 500) or downward ferritin trend inspite of reduction of chelation dose over the last 6 months. They will be subjected to discontinuation of their chelation therapy.
Drug: desferal, ferriprox, blood transfusion

Deferiprone (75-100 mg/kg/d) and deferoxamine (20-60 mg/kg/d) aimed at achieving "normal" body iron stores in poly-transfued arm1.

Arm 2 will only recieve blood transfusion with no chelation

Other Names:
  • deferiprone
  • deferoxamine

Detailed Description:
Treatment of transfusional iron overload in TM patients with low serum ferritin (continued decrease in serum ferritin ) even after reduction of chelation dose.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Subjects with low transfusional iron overload secondary to thalassemia major showing downward-trend in SF over last 6 months ( 2 readings are needed).

    • Thalassemia major patients with SF equal or less than 500 after reduction of chelation dose. Patients on different types of chelation monotherapy will be included
    • The subjects must also have a level of understanding and willingness to cooperate with the confinement and procedures described in the consent form and scheduled by the study site. In addition, he/she must be able to provide voluntary written informed assent or consent forms.

Exclusion Criteria:

  • subjects with HIV positive or have active HCV.
  • A history of serious immunologic hypersensitivity to any medication such as anaphylaxis or angioedema.
  • Participation in a previous investigational drug study within the 30 days preceding screening.
  • A woman of childbearing potential must have a negative serum pregnancy test at screening. She must use a medically acceptable form of birth control during the study and for a month afterwards who are pregnant or breast-feeding.
  • An inability to adhere to the designated procedures and restrictions of this protocol.
  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): NCT01996683


Contacts
Contact: Amira A M Adly, Asst. prof 01005245837 amiradiabetes@yahoo.com
Contact: Yasmine I Elhenawy, lecturer 01004084038 dr_yasmi@yahoo.com

Locations
Egypt
Pediatric Hematology clinic, Ain Shams University Not yet recruiting
Cairo, Egypt
Principal Investigator: Mohsen S Elalfy, professor         
Sub-Investigator: Amira A Adly, Assist. prof.         
Sub-Investigator: Yasmine I Elhenawy, lecturer         
Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: Mohsen S. Elalfy, professour Ain Shams University
  More Information

Responsible Party: Mohsen Saleh Elalfy, professor of pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT01996683     History of Changes
Other Study ID Numbers: iron chelation in thalassemia
First Submitted: November 22, 2013
First Posted: November 27, 2013
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by Mohsen Saleh Elalfy, Ain Shams University:
B-thalassemia
ferritin

Additional relevant MeSH terms:
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