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NCT Number: NCT06314529

Long-term Follow-up Study of BHC001 for TDT

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

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Key information

Conditions

Thalassemia, Beta Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia beta-Thalassemia

Age range

5 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army, Nanning, Guangxi, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessments

Other

Safety and efficacy assessments

Primary outcomes

  1. Incidence of hematologic malignancies

    Time frame: Up to 15 years post-drug product infusion

    Such as new lymphoma, leukemia, MDS, etc.

  2. Frequency, grade, and relationship of SAEs

    Time frame: Within 2 years to 5years after BRL-101 Infusion

    Frequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaochen Wang, PhD

CONTACT

[email protected]

021-64340008

Sponsors and collaborators

Lead sponsor

Bioray Laboratories

Industry

Collaborators

  • The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
  • Xiangya Hospital of Central South University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2036
Study completion
2037
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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