Thalassemia Majors (Beta-Thalassemia Major)NCT07509996
Risk Factors Affecting Growth in Thalassemic Children at AUCH
An observational study of Thalassemia Majors (Beta-Thalassemia Major), run by Assiut University.
Trial summary
Thalassemia major is a hereditary hemoglobinopathy characterized by ineffective erythropoiesis and severe anemia, necessitating lifelong blood transfusions(1,2). Regular transfusions lead to iron overload, a primary driver of growth retardation in affected children. Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Thalassemia Majors (Beta-Thalassemia Major)
- What is being tested?
- Non-interventional assessment of growth and risk factors in thalassemic children
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 May 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 18 years
- All sexes
- Child, Adult
Study population: All children with transfusion-dependent beta-thalassemia major attending the AUCH Hematology Unit will be screened for eligibility.
Who may be able to join
- Children aged 1 to 18 years diagnosed with β-thalassemia major based on hemoglobin electrophoresis or high-performance liquid chromatography (HPLC).
- Receiving regular blood transfusions as part of standard management at AUCH.
- Attending the hematology unit for at least one year prior to enrollment.
Who cannot join
- • Children with other types of thalassemia.
- Presence of congenital diseases, chronic illnesses other than thalassemia (e.g., malignancy, tuberculosis, chronic hepatitis, congenital heart disease, chronic renal failure, epilepsy, diabetes mellitus), or primary endocrinopathies.
- Patients with other causes of short stature, such as hereditary bone dysplasia or systemic disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Different Risk Factors on Growth Parameters of Thalassemic Patients in Assiut University Children Hospital
Thalassemia major is a hereditary hemoglobinopathy characterized by ineffective erythropoiesis and severe anemia, necessitating lifelong blood transfusions(1,2). Regular transfusions lead to iron overload, a primary driver of growth retardation in affected children. Iron accumulation in tissues like the pituitary and liver disrupts growth hormone secretion and insulin-like growth factor-1 production.
- Being tested
- Non-interventional assessment of growth and risk factors in thalassemic children
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional assessment of growth and risk factors in thalassemic childrenOther
No therapeutic intervention is applied. The study involves only observational assessment of clinical history, anthropometric measurements, laboratory investigations, and growth parameters in thalassemic children. This distinguishes it from interventional studies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth parameters: Z-scores for height-for-age, weight-for-age, BMI-for-age
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thalassemia Majors (Beta-Thalassemia Major)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Saleh Sadek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509996
- Sponsor's protocol ID
- AUCH-TP-2026-01
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Risk Factors on Growth Parameters of Thalassemic Patients in Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT07509996
- Acronym / sponsor ID
- AUCH-TP-2026-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thalassemia major is a hereditary hemoglobinopathy characterized by ineffective erythropoiesis and severe anemia, necessitating lifelong blood transfusions(1,2). Regular transfusions lead to iron overload, a primary driver of growth retardation in affected children. Iron accumulation in tissues like the pituitary and liver disrupts growth hormone secretion and insulin-like growth factor-1 production.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All children with transfusion-dependent beta-thalassemia major attending the AUCH Hematology Unit will be screened for eligibility.
Key inclusion criteria (3 listed)
- Children aged 1 to 18 years diagnosed with β-thalassemia major based on hemoglobin electrophoresis or high-performance liquid chromatography (HPLC).
- Receiving regular blood transfusions as part of standard management at AUCH.
- Attending the hematology unit for at least one year prior to enrollment.
Key exclusion criteria (3 listed)
- • Children with other types of thalassemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional assessment of growth and risk factors in thalassemic childrenNo therapeutic intervention is applied. The study involves only observational assessment of clinical history, anthropometric measurements, laboratory investigations, and growth parameters in thalassemic children. This distinguishes it from interventional studies. | Other | – |
Primary outcome
Growth parameters: Z-scores for height-for-age, weight-for-age, BMI-for-age
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia Majors (Beta-Thalassemia Major), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Sale Sadek (+20 1555112872, assemaya8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth parameters: Z-scores for height-for-age, weight-for-age, BMI-for-age (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.