Long-term Follow-up Study of BHC001 for TDT

March 11, 2024 updated by: Bioray Laboratories

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
        • Contact:
          • Xinhua Zhang, phD
    • Hunan
      • Changsha, Hunan, China, 510510
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
          • Bin Fu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects with transfusion-dependent β-thalassemia who have been treated with BHC001.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BRL-101
All patients who have received BRL-101
Other: Assessments
Safety and efficacy assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hematologic malignancies
Time Frame: Up to 15 years post-drug product infusion
Such as new lymphoma, leukemia, MDS, etc.
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
Frequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion
Within 2 years to 5years after BRL-101 Infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioray Laboratories

Collaborators

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

Investigators

  • Study Chair: Xiaochen Wang, PhD, Bioray Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Estimated)

December 10, 2036

Study Completion (Estimated)

May 10, 2037

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-LTF-BHC001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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