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

NCT ID: NCT06298630

Last Updated: 2024-03-22

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

NOT_YET_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-08

Study Completion Date

2038-10-15

Brief Summary

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

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 BRL-101 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

3 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army

OTHER

Sponsor Role collaborator

Shenzhen Children 's Hospital

UNKNOWN

Sponsor Role collaborator

Bioray Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaochen Wang

Role: STUDY_CHAIR

Bioray Laboratories

Locations

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Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Shenzhen Children 's Hospital

Shenzhen, Guangdong, China

Site Status

No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital

Nanning, Guangxi, China

Site Status

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Tianjin Institute of Hematology

Tianjin, Tianjin Municipality, China

Site Status

The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY

Guangxi, , China

Site Status

Countries

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China

Central Contacts

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Xiaochen Wang, phD

Role: CONTACT

021-64340008

Facility Contacts

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Xiaoqin Feng, phD

Role: primary

Jianpei Fang, phD

Role: primary

Sixi Liu, phD

Role: primary

Xinhua Zhang, phD

Role: primary

Bin Fu, PhD

Role: primary

Jun shi, PhD

Role: primary

Yongrong Lai, PhD

Role: primary

Other Identifiers

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2022-LTF-BRL-101

Identifier Type: -

Identifier Source: org_study_id

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