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

Ain Shams University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Iron Chelation; Vitamin c; Thalassemia Major

Treatments: Drug: Vitamin C, Defriprone, deferisarox; Drug: deferiprone , deferesarox

Study type: Interventional

Funder types: Other

Identifiers

NCT02083575

vitamin c and iron chelator

Details and patient eligibility

About

role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.

Full description

assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

vitamin c

Active Comparator group

Description:

25 heavily iron-loaded thalassemia patients, receiving adjuvant vitamin c with iron chelator.

Treatment:

Drug: Vitamin C, Defriprone, deferisarox

iron chelator

Other group

Description:

Included 25 heavily iron-loaded thalassemia patients, not receiving adjuvant vitamin c with iron chelator.

Treatment:

Drug: deferiprone , deferesarox