Beta ThalassemiaNCT04917978
Association of Hb F Level With Clinical Severity of Beta Thalassemia
An observational study of Beta Thalassemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The production of Hb F after birth is an important factor in modifying the clinical severity of beta thalassemia because an increased gamma-globin level will bind the additional a-globin and form Hb F. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Beta Thalassemia
- What is being tested?
- Hematological Phenotype Analysis
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 30 Dec 2025
- 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: β-thalassemia patients from Southern China
Who may be able to join
- Diagnosed with beta-thalassemia
Who cannot join
- Iron Deficiency Anemia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern Medical University
Guangzhou, Guangdong, 510515
Xiangmin Xu, Prof. Dr., 02061648293 ext. 86, xixm@smu.edu.cn
About this study
The production of Hb F after birth is an important factor in modifying the clinical severity of beta thalassemia because an increased gamma-globin level will bind the additional a-globin and form Hb F. The objective of this project is to evaluate the association of Hb F level with phenotypic diversity of patients with beta thalassemia.
- Conditions
- Beta Thalassemia
- Being tested
- Hematological Phenotype Analysis
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematological Phenotype AnalysisDiagnostic test
Hematological parameters were determined with an automated hematology analyzer (Sysmex, Japan), and hemoglobin analysis was performed with either high-performance liquid chromatography (Bio- Rad, USA) or capillary electrophoresis (Sebia, France and Helena, USA).
| Study group | Role | What they receive |
|---|---|---|
| beta thalassemia patients | Not described Receives: Diagnostic Test: Hematological Phenotype Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb F level and severity of anemia
Observational study that analyzed association of Hb F level and anemia severity in patients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Dec 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta ThalassemiaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- ZhuHai Hospital, Shenzhen Children's Hospital, Shenzhen Second People's Hospital, Jiangmen Maternity and Child Health Care Hospital, Yongzhou Maternity and Child Health Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917978
- Sponsor's protocol ID
- HbF-Beta thalassemia
- Status last verified
- May 2021
- First submitted
- 3 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Hb F Level With Clinical Severity of Beta Thalassemia
- ClinicalTrials.gov ID
- NCT04917978
- Acronym / sponsor ID
- HbF-Beta thalassemia
- Conditions
- Beta Thalassemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- ZhuHai Hospital, Shenzhen Children's Hospital, Shenzhen Second People's Hospital, Jiangmen Maternity and Child Health Care Hospital, Yongzhou Maternity and Child Health Hospital
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Jun 2021 (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.
The production of Hb F after birth is an important factor in modifying the clinical severity of beta thalassemia because an increased gamma-globin level will bind the additional a-globin and form Hb F. The objective of this project is to evaluate the association of Hb F level with phenotypic diversity of patients with beta thalassemia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| beta thalassemia patients | – | Diagnostic Test: Hematological Phenotype Analysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- β-thalassemia patients from Southern China
Key inclusion criteria (1 listed)
- Diagnosed with beta-thalassemia
Key exclusion criteria (1 listed)
- Iron Deficiency Anemia
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 |
|---|---|---|
| Hematological Phenotype AnalysisHematological parameters were determined with an automated hematology analyzer (Sysmex, Japan), and hemoglobin analysis was performed with either high-performance liquid chromatography (Bio- Rad, USA) or capillary electrophoresis (Sebia, France and Helena, USA). | Diagnostic test | beta thalassemia patients |
Primary outcome
Hb F level and severity of anemia
Time frame: 3 years
Observational study that analyzed association of Hb F level and anemia severity in patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
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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.
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 Beta Thalassemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangmin Xu, Prof. Dr. (02061648293 ext. 86, xixm@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hb F level and severity of anemia (time frame: 3 years). 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 11 Jun 2021.