Long-term observation of BHC001 treatment for beta thalassemia
Official title: Long-term Follow-up Study of BHC001 in the Treatment of Transfusion-dependent β-thalassemia
Run by Bioray Laboratories · NCT06314529 · Data updated 2026-11-12
This study looks at the long-term safety and effects of a treatment called BHC001 in people with beta thalassemia who need regular blood transfusions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Years to 35 Years |
| Sex | All |
| Enrollment | 6 (estimated) |
| Sponsor | Bioray Laboratories Industry-sponsored |
| Locations | 2 sites (Nanning, Guangxi and 1 other locations) |
| Status | Recruiting |
| Started | December 14, 2022 |
| Main results expected | December 10, 2036 |
| Study ends | May 10, 2037 |
| Registry record updated | March 18, 2024 |
| Trial ID | NCT06314529 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals with transfusion-dependent beta thalassemia who have previously been treated with BRL-101.
✕Probably not a fit
Patients who have not been treated with BRL-101 or those with other forms of thalassemia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study observes the long-term safety and efficacy of BHC001 in patients with transfusion-dependent beta thalassemia (TDT). Participants who have been treated with BRL-101 will be monitored for delayed safety risks, including the emergence of neoplasms and hematological disorders. The study aims to gather comprehensive data on the long-term effects of the treatment following intravenous infusion. It is an observational study, meaning it will focus on collecting data without any experimental intervention.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of BHC001 for patients with beta thalassemia.
How similar studies have gone: While this study focuses on long-term effects, similar observational studies have shown success in monitoring treatment outcomes in chronic conditions, suggesting a potential for valuable findings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s) 2. Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia. Exclusion Criteria: \- There are no exclusion criteria for this study
Where it's running
-
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
Nanning, Guangxi, China Recruiting -
Xiangya Hospital of Central South University
Changsha, Hunan, China Recruiting
Study contacts
- Study coordinator: Xiaochen Wang, PhD
- Email: xcwang@brlmed.com
- Phone: 021-64340008
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Long-term safety and effectiveness of BRL-101 in transfusion-dependent beta-thalassemia
This study looks at whether BRL-101 remains safe and effective over the long term for people with transfusion-dependent beta-thalassemia.
-
Investigating genetic factors in blood disorders
This study is trying to find out how genes affect blood disorders like sickle cell disease and thalassemia by looking at the DNA of many people with these conditions.
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Immune suppression treatment for sickle cell disease and beta-thalassemia patients receiving stem cell transplants
This study is testing if a new immune suppression treatment can help people with sickle cell disease or beta-thalassemia have better outcomes when they receive stem cell transplants.
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Combining Thalidomide with Danazol and Prednisolone for difficult beta-thalassemia in children
This trial tests whether adding danazol and prednisolone to thalidomide helps children with transfusion-dependent beta-thalassemia who did not respond to thalidomide alone.
-
Partial stem cell transplant for sickle cell disease and beta-thalassemia using matched donors
This study tests a partial stem cell transplant from matched donors to help people with severe sickle cell disease or beta-thalassemia see if more donor cells can persist long-term.
-
Testing 9MW3011 for patients with non-transfusion-dependent beta-thalassemia
This study is testing a new drug called 9MW3011 to see if it is safe and effective for people with non-transfusion-dependent beta-thalassemia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.