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Trial record 8 of 12 for:    serum ferritin | "Thalassemia" | "Deferiprone"

Role of Vitamin C to Augment Iron Chelation With DFP or DFX

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ClinicalTrials.gov Identifier: NCT02083575
Recruitment Status : Unknown
Verified March 2014 by Mohsen Saleh Elalfy, Ain Shams University.
Recruitment status was:  Not yet recruiting
First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University

Tracking Information
First Submitted Date  ICMJE March 7, 2014
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date March 11, 2014
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • Vit C to Augment iron chelation [ Time Frame: 12 months ]
    assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
  • vitamin c augmenting effect of iron chelator [ Time Frame: 12 month ]
    better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
adverse related events [ Time Frame: 12 month ]
safety and occurrence of AEs in both studied groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Vitamin C to Augment Iron Chelation With DFP or DFX
Official Title  ICMJE Study of Safty and Efficacy of Adjuvant Vitamin c in Augmenting Iron Chelation
Brief Summary role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
Detailed Description assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Vitamin c
  • Thalassemia Major
  • Iron Chelation
Intervention  ICMJE
  • Drug: Vitamin C, Defriprone, deferisarox
    adjuvant vitamin c with iron chelator.
    Other Names:
    • vitamin c
    • DFP
    • DFX
  • Drug: deferiprone , deferesarox
    iron chelator
    Other Names:
    • DFP
    • DFX
Study Arms  ICMJE
  • Active Comparator: vitamin c
    25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator.
    Intervention: Drug: Vitamin C, Defriprone, deferisarox
  • iron chelator
    Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator.
    Intervention: Drug: deferiprone , deferesarox
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 7, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • Subjects with overload secondary to thalassemia major

Exclusion Criteria:

  • • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02083575
Other Study ID Numbers  ICMJE vitamin c and iron chelator
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohsen Saleh Elalfy, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: MOHSEN S ELALFY, PROF. Ain Shams University
PRS Account Ain Shams University
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP