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

Phase 2

• Conditions: Vitamin c; Iron Chelation; Thalassemia Major
• Interventions: Drug: Vitamin C, Defriprone, deferisarox; Drug: deferiprone , deferesarox

• Registration Number: NCT02083575
• Lead Sponsor: Ain Shams University

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 Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-07
• Last Update Submitted: 2014-03-07
• Study First Posted: 2014-03-11
• Last Update Posted: 2014-03-11
• Study Start: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
vitamin c	Vitamin C, Defriprone, deferisarox	25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator.
iron chelator	deferiprone , deferesarox	Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator.

Primary Outcome Measures

Name	Time	Method
Vit C to Augment iron chelation	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	12 month	better reduction in serum ferritin, LIC and cardiac T28 in group receiving vitamin c

Secondary Outcome Measures

Name	Time	Method
adverse related events	12 month	safety and occurrence of AEs in both studied groups

Trial Locations

Locations (1)

Pediatric Hematology clinic, Ain Shams University Egypt; 🇪🇬 Cairo,, Egypt