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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)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01996683
First received: November 22, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 2014
Estimated Primary Completion Date: November 2014 (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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 22, 2013
Last Updated: November 22, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams University:
B-thalassemia
ferritin

Additional relevant MeSH terms:
Iron Chelating Agents
Chelating Agents
Beta-Thalassemia
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Deferoxamine
Deferiprone
Siderophores
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014