Long-term Follow-up Study of BRL-101 for TDT

Bioray Laboratories

Status: Not yet enrolling

Conditions: Thalassemia, Beta

Treatments: Other: Assessments

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06298630

2022-LTF-BRL-101

Details and patient eligibility

About

Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.

Full description

Observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.

Enrollment: 45 estimated patients

Sex: All

Ages: 3 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 1 patient group

BRL-101

Description:

All patients who have received BRL-101

Treatment:

Other: Assessments