Actively Recruiting

Phase Not Applicable
Age: 2Years - 18Years
All Genders
ID06568926

Adherence of Beta Thalassemia Patients to Oral Chelation Therapy

Led by Sohag University · Updated on 2024-08-23

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Beta-thalassemias are inherited blood disorders causing chronic anemia due to problems with hemoglobin production. The severity varies, influencing the need for regular blood transfusions. This research focuses on patients with beta-thalassemia, especially those dependent on transfusions, and evaluates their adherence to oral iron chelation therapy, which is crucial for managing iron overload. The study is sponsored by Sohag University and aims to understand treatment compliance in children and adolescents aged 2 to 18 years. Participants in this study are patients with beta-thalassemia major or intermedia who have been receiving regular blood transfusions every 2 to 5 weeks. They are prescribed oral iron chelation therapy using deferasirox, which they must have taken for at least one year before joining the study. The study follows these patients over one year to monitor their serum ferritin levels, a marker of iron in the body, to assess adherence to the oral treatment. During the study, participants will have their ferritin levels regularly checked to monitor how well they follow the oral therapy. Researchers will also observe any side effects or complications related to the treatment. The total participation period is one year, during which the patient’s iron levels and overall management will be closely reviewed to better understand real-world adherence to oral chelation therapy in this population.

CONDITIONS

Brief Title

Adherence of Beta Thalssemia Patients to Oral Chelation Therapy

Who Can Participate

Age: 2Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of beta thalassemia major or intermedia
  • Age between 2 and 18 years
  • Receiving regular blood transfusions every 2 to 5 weeks
  • Prescribed oral iron chelation therapy with deferasirox for at least 1 year prior to enrollment
Not Eligible

You will not qualify if you...

  • Age less than 2 years or more than 18 years
  • Blood transfusions due to causes other than beta thalassemia
  • Currently using deferoxamine as iron chelation therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - 1 year

Participants are monitored for serum ferritin levels while on oral chelation therapy.

Trial Site Locations

Total: 1 location

1

Sohag university Hospital

Sohag, Egypt

Actively Recruiting

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Research Team

M

Marwa Ali Mousa, resident

A

ALzahraa Elsayad Ahmed, professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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Published Research Related To This Trial

Consequences and costs of noncompliance with iron chelation therapy in patients with transfusion-dependent thalassemia: a literature review.

Thomas E Delea, John Edelsberg, Oleg Sofrygin...

https://pubmed.ncbi.nlm.nih.gov/17880620

Compliance score as a monitoring tool to promote treatment adherence in children with thalassemia major for improved physical growth.

Sarala Kannan, Amarjeet Singh

https://pubmed.ncbi.nlm.nih.gov/28970676

Neutropenia and Life-threatening Agranulocytosis Among Children With β-Thalassemia Treated With Oral Iron Chelators in a Community With Background of Ethnic Neutropenia.

Hanan F Nazir, Maryam Alshizawi

https://pubmed.ncbi.nlm.nih.gov/31876777