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Recruiting NCT06314529

Long-term Follow-up Study of BHC001 for TDT

— Observational Thalassemia, Beta

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessments.
Who it may be relevant to
Registry conditions: Thalassemia, Beta. Basic parameters: 5 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long-term Follow-up Study of BHC001 in the Treatment of Transfusion-dependent β-thalassemia

Overview

Observe long-term safety risk and long-term efficacy after intravenous infusion of BHC001 in TDT subjects.

Detailed description

Observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of BHC001 in TDT subjects.

Interventions

  • Other Assessments
    Safety and efficacy assessments

Primary outcome measures

  • Incidence of hematologic malignancies [Time frame: Up to 15 years post-drug product infusion]
  • Frequency, grade, and relationship of SAEs [Time frame: Within 2 years to 5years after BRL-101 Infusion]

Eligibility criteria

Inclusion criteria

  • Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s)
  • Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia.

Exclusion criteria

\- There are no exclusion criteria for this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 2 centers
  • The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army — Nanning
  • Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT06314529 · 2022-LTF-BHC001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗