Long-term Follow-up Study of BHC001 for TDT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-14

Study Completion Date

2037-05-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Thalassemia, Beta

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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BRL-101

All patients who have received BRL-101

Assessments

Intervention Type OTHER

Safety and efficacy assessments

Interventions

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Assessments

Safety and efficacy assessments

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No