Pharmacotherapy Prescribing Pattern and the Adherence Level to Iron Chelation Therapy in Thalassemia

NCT ID: NCT06210139

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-28

Study Completion Date

2024-02-28

Brief Summary

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Thalassemias are a heterogeneous grouping of genetic disorders that result in dysfunctional Hb, reduced RBC life span leading to chronic anemia . Thalassemia is endemic in the Middle East. Iron chelation therapy (ICT) is one of treatment used however ICT is associated with patients adherence problem thus impacting its effectiveness .

Detailed Description

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Thalassemias are a heterogeneous grouping of genetic disorders that result from a decreased synthesis of alpha or beta chains of hemoglobin resulting in dysfunctional Hb, reduced RBC life span and hemolytic anemia as well as ineffective erythropoiesis leading to chronic anemia. Thalassemia is endemic in the Middle East, the Mediterranean region, and Southeast Asia, its prevalence in these region range from 7%-10%. There are 3 iron chelators licensed for clinical use, namely, deferoxamine (DFO), deferiprone (DFP), and deferasirox (DFX). Advancement in blood transfusions and ICT transforms this disease from fatal childhood disease to adult chronic disease . From other side, thalassemic patients on ICT suffering from therapy related challenge such as nonadherence, Nonadherence to ICT remains a long-standing and serious issue in thalassemia with ranges from 30% to 80% World widely. Issue of nonadherence and suboptimal responsiveness to ICT is complex and multifactorial such as side effects and administrations on top of inadequate knowledge and practice lead to reduced adherence to ICT thus increasing morbidity and mortality

Conditions

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Thalassemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* male and female patients with age above 3 years old diagnosed with thalassemia,
* having iron overload
* taken Iron chelation therapy
* having the acceptance to participate in the study.

Exclusion Criteria

* renal and hepatic impairment,
* Allergic to any drug of the study
* history of viral hepatitis or HIV
* Gastrointestinal disorder affecting drug absorption.
* psychiatric disorder affecting consent agreement and unable to comply with study.
Minimum Eligible Age

3 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reem Ali Shaker

OTHER

Sponsor Role lead

Responsible Party

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Reem Ali Shaker

Principle investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fadhil A Riziji, PhD

Role: STUDY_DIRECTOR

Kufa university/ faculty of pharmacy

Locations

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AL Zahar teaching Hospital

Najaf, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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MEC-40

Identifier Type: -

Identifier Source: org_study_id

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