Long-term Follow-up Study of BHC001 for TDT
ConditionThalassemia, Beta
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-35
SponsorBioray Laboratories
About this trial
Observe long-term safety risk and long-term efficacy after intravenous infusion of BHC001 in TDT subjects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Subjects with transfusion-dependent β-thalassemia who have been treated with BHC001.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Assessments
Other interventionSafety and efficacy assessments
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: BRL-1011 intervention
Trial outcomes
Primary outcomes
1
Incidence of hematologic malignancies
Such as new lymphoma, leukemia, MDS, etc.
Time frame
Up to 15 years post-drug product infusion2
Frequency, grade, and relationship of SAEs
Frequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion
Time frame
Within 2 years to 5years after BRL-101 InfusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bioray Laboratories
Lead sponsor
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
Collaborator
Xiangya Hospital of Central South University
Collaborator
Source ClinicalTrials.gov