HemoglobinopathiesHb variantsNCT07207551
Prevalence of Hemoglobinopathies Associated With Significant Hb Variants in the Chattogram Region of Bangladesh
An observational study of Hemoglobinopathies, run by Bangladesh Bioscience Research Group at 1 site in Bangladesh.
Trial summary
Hemoglobinopathies represent a collection of genetic conditions that influence the structure or synthesis of haemoglobin, the protein found in red blood cells that facilitates oxygen transport from the lungs throughout the body. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemoglobinopathies
- How many people
- 760 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2023to 4 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population will consist of individuals from the selected community and healthcare facilities who meet the inclusion criteria. Participants of all ages and both sexes will be included, provided they give informed consent and have not received a blood transfusion within the last three months. The population is expected to represent a cross-section of healthy individuals and those with suspected or confirmed hemoglobinopathies, allowing for assessment of hemoglobin variants and related biochemical parameters.
Who may be able to join
- Residents of the Chattogram metropolitan area.
- All ages and both sexes with informed consent.
- Willing to provide venous blood samples.
- No blood transfusion in the past 3 months.
Who cannot join
- Refusal or withdrawal of consent.
- Blood transfusion within the last 3 months.
- Pregnant women.
- Inadequate or hemolyzed blood samples.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
University of Science and Technology Chittagong (USTC)
Khulshi, Chattogram, 4203
About this study
Official title: Prevalence of Hb Variants and Haemoglobinopathies in a Tertiary Care Hospital: A Retrospective Cross-sectional Study
Hemoglobinopathies represent a collection of genetic conditions that influence the structure or synthesis of haemoglobin, the protein found in red blood cells that facilitates oxygen transport from the lungs throughout the body. This research proposal presents a study evaluating the prevalence of hemoglobinopathies and their significant haemoglobin variants within a specific population. The research will employ a cross-sectional study design, recruiting participants through community outreach efforts and healthcare facilities while obtaining informed consent. Data will be collected with the utmost precision and rigor, using advanced screening techniques such as high-performance liquid chromatography (HPLC), capillary electrophoresis, and molecular analysis. The gathered data will be processed to assess haematological parameters, including RBC, Iron Ferritin, TIBC, electrophoresis profiles (HbA, HbA2, HbE, HbF), MCV, MCHC, and PCV among individuals with hemoglobinopathies (HbE disease/trait, Beta thalassemia disease/trait, heterozygous HPFH, HbE-beta thal). They will examine variations relative to demographic factors. The expected results will have substantial clinical and public health consequences by enhancing genetic counselling, informing clinical decision-making, and strengthening public health initiatives.
Read the detailed description
Hemoglobinopathies are genetic disorders affecting the structure or production of hemoglobin, the oxygen-carrying protein in red blood cells. This study aims to determine the prevalence and major variants of hemoglobinopathies in a target population using a cross-sectional design. Participants will be recruited through community outreach and healthcare facilities with informed consent. Screening will involve advanced techniques such as HPLC, capillary electrophoresis, and molecular analysis, alongside hematological assessments (RBC, ferritin, TIBC, MCV, MCHC, PCV, and hemoglobin profiles: HbA, HbA2, HbE, HbF). Findings will be analyzed in relation to demographic factors.
- Conditions
- Hemoglobinopathies
- Keywords
- Hb Variants, HbE Trait, Beta Thalassemia, Iron Profile, Peripheral Blood Film (PBF)
- Medical subject headings
- Hemoglobinopathies, beta-Thalassemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Hemoglobin Variants by Hb-Electrophoresis
Performed to detect hemoglobin variants (e.g., HbA, HbE, HbS, HbC, HbD, HbF). The outcome will report the number and percentage of participants with each variant.
Measured: Day 1, at enrollment
Secondary outcomes (1)
Correlation of Hematological Parameters with Demographic Factors
Statistical correlation between hematological indices and demographic factors (eg. age, sex, family history).
Measured: Day 1, upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Jun 2023
- Primary completion17 Jun 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoglobinopathiesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 760 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bangladesh Bioscience Research Group
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Pair Ahmed Jiko, Chittagong Medical College
- Investigators
- PAIR AHMED JIKO, Lab-Incharge (Biochemist), Principal investigator, Institute Of Applied Health Sciences Hospital-USTC (Ex-BBMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207551
- Sponsor's protocol ID
- BBMH/2024/RP-2412
- Other IDs
- BBMH/January/2024/024
- Acronym
- Hb variants
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared with other researchers to protect patient confidentiality and comply with institutional and ethical guidelines. Only aggregated, de-identified data may be shared upon reasonable request and with appropriate ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hb Variants and Haemoglobinopathies in a Tertiary Care Hospital: A Retrospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07207551
- Acronym / sponsor ID
- Hb variants / BBMH/2024/RP-2412
- Conditions
- Hemoglobinopathies
- Keywords
- Hb Variants, HbE Trait, Beta Thalassemia, Iron Profile, Peripheral Blood Film (PBF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Bangladesh Bioscience Research GroupResearch network
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 6 Oct 2025 (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.
Hemoglobinopathies represent a collection of genetic conditions that influence the structure or synthesis of haemoglobin, the protein found in red blood cells that facilitates oxygen transport from the lungs throughout the body. This research proposal presents a study evaluating the prevalence of hemoglobinopathies and their significant haemoglobin variants within a specific population. The research will employ a cross-sectional study design, recruiting participants through community outreach efforts and healthcare facilities while obtaining informed consent. Data will be collected with the utmost precision and rigor, using advanced screening techniques such as high-performance liquid chromatography (HPLC), capillary electrophoresis, and molecular analysis. The gathered data will be processed to assess haematological parameters, including RBC, Iron Ferritin, TIBC, electrophoresis profiles (HbA, HbA2, HbE, HbF), MCV, MCHC, and PCV among individuals with hemoglobinopathies (HbE disease/trait, Beta thalassemia disease/trait, heterozygous HPFH, HbE-beta thal). They will examine variations relative to demographic factors. The expected results will have substantial clinical and public health consequences by enhancing genetic counselling, informing clinical decision-making, and strengthening public health initiatives.
Detailed description
Hemoglobinopathies are genetic disorders affecting the structure or production of hemoglobin, the oxygen-carrying protein in red blood cells. This study aims to determine the prevalence and major variants of hemoglobinopathies in a target population using a cross-sectional design. Participants will be recruited through community outreach and healthcare facilities with informed consent. Screening will involve advanced techniques such as HPLC, capillary electrophoresis, and molecular analysis, alongside hematological assessments (RBC, ferritin, TIBC, MCV, MCHC, PCV, and hemoglobin profiles: HbA, HbA2, HbE, HbF). Findings will be analyzed in relation to demographic factors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population will consist of individuals from the selected community and healthcare facilities who meet the inclusion criteria. Participants of all ages and both sexes will be included, provided they give informed consent and have not received a blood transfusion within the last three months. The population is expected to represent a cross-section of healthy individuals and those with suspected or confirmed hemoglobinopathies, allowing for assessment of hemoglobin variants and related biochemical parameters.
Key inclusion criteria (4 listed)
- Residents of the Chattogram metropolitan area.
- All ages and both sexes with informed consent.
- Willing to provide venous blood samples.
- No blood transfusion in the past 3 months.
Key exclusion criteria (4 listed)
- Refusal or withdrawal of consent.
- Blood transfusion within the last 3 months.
- Pregnant women.
- Inadequate or hemolyzed blood samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of Hemoglobin Variants by Hb-Electrophoresis
Time frame: Day 1, at enrollment
Performed to detect hemoglobin variants (e.g., HbA, HbE, HbS, HbC, HbD, HbF). The outcome will report the number and percentage of participants with each variant.
1 secondary outcome
Correlation of Hematological Parameters with Demographic Factors
Time frame: Day 1, upon enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared with other researchers to protect patient confidentiality and comply with institutional and ethical guidelines. Only aggregated, de-identified data may be shared upon reasonable request and with appropriate ethical approvals.
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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. This study is not recruiting at the moment.
PAIR AHMED JIKO, Lab-Incharge (Biochemist) principal investigator
Institute Of Applied Health Sciences Hospital-USTC (Ex-BBMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoglobinopathies, run by Bangladesh Bioscience Research Group at 1 site in Bangladesh.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Hemoglobin Variants by Hb-Electrophoresis (time frame: Day 1, at enrollment). 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 6 Oct 2025.