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An Algorithm to Start Iron Chelation in Minimally Transfused Young Beta-thalassemia Major Patients

NCT02173951 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2015-01-14

No results posted yet for this study

Summary

A prospective randomized study on Safety, Tolerability and Efficacy of oral Low dose DFP (50 mg/kg/day) in minimally transfused B-TM after 5 transfusions when SF reaches 500 ng/m and with either appearance of LPI \> 0.2 or TSAT reaches 50% compared with non treatment arm.

So the aim of this study:

1. To determine the time as well as amount of transfused iron ( calculated in mg iron/kg ) which lead to Serum ferritin reaches 500 ng /ml and LPI appearance \>0.2 as well as TSAT reaches 50 % .
2. Tolerability and safety of early low dose DFP 50mg/kg and effectiveness to postpone or prevent SF from reaching 1000 ng/ml or LPI \>0.6 or TSAT \>70% in comparison to patients not starting chelation therapy
3. Determine adverse events whether drug or non drug related

Conditions

  • Beta Thalassemia Major

Interventions

DRUG

Deferiprone

in arm 1 ( active comparator) will receive a starting dose of Deferiprone (DFP) 50mg⁄ kg ⁄ d, administered orally 3 times daily. Routine dose adjustments will be made according to serum ferritin trends and safety. Patients reaching serum ferritin ≥1000 will be subjected to dose escalation of DFP to 75 mg/kg/d. Patients in Placebo Comparator arm when reaching end point elevation of SF to around 1000 ng/ml or more or Tsat \> 90 % and or LPI \> 0.6 will start deferiprone 75 mg/kg/d

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mohsen S Elalfy, professour · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02173951 on ClinicalTrials.gov