Long-term observation of BHC001 treatment for beta thalassemia
Long-term Follow-up Study of BHC001 in the Treatment of Transfusion-dependent β-thalassemia
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 |
|---|---|
| Enrollment | 6 (estimated) |
| Ages | 5 Years to 35 Years |
| Sex | All |
| Sponsor | Bioray Laboratories Industry-sponsored |
| Locations | 2 sites (Nanning, Guangxi and 1 other locations) |
| Trial ID | NCT06314529 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with transfusion-dependent beta thalassemia who have previously been treated with BRL-101.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanning, Guangxi and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.