Long-term Follow-up Study of BHC001 for TDT | NCT06314529

Studies
Long-term Follow-up Study of BHC001 for TDT

NCT06314529

Sponsor

Bioray Laboratories

Status

Recruiting

Last Update Posted

Mar 18, 2024Actual

Enrollment

6Estimated

Phase

Not provided

Conditions

Thalassemia, Beta

Interventions

Assessments

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2022Actual

Primary Completion Date

Dec 10, 2036Estimated

Completion Date

May 10, 2037Estimated

First Submitted Date

Mar 6, 2024

First Submission Date that Met QC Criteria

Mar 11, 2024

First Posted Date

Mar 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2024

Last Update Posted Date

Mar 18, 2024Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BRL-101		All patients who have received BRL-101	Other: Assessments

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessments	Other	Safety and efficacy assessments	BRL-101

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaochen Wang, PhD	Contact	021-64340008		xcwang@brlmed.com

Overall Officials

Name	Affiliation	Role
Xiaochen Wang, PhD	Bioray Laboratories	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army	Recruiting	Nanning	Guangxi	530021	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017086	beta-Thalassemia

Ancestor Terms

ID	Term
D013789	Thalassemia
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia

Browse Leaves

Not provided

Browse Branches

Not provided