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Clinical Trial Report

Gene Therapy Trial Report

Summary

Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs


NCTID NCT06111638 (View at clinicaltrials.gov)
Description
Indication Hemophilia A
Compound Name BBM-H803
Sponsor Shanghai Belief-Delivery BioMed Co., Ltd
Funder Type Industry
Status
Recruiting
Enrollment Count 12

Therapy Information


Target Gene/Variant F8
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Functional gene replacement
Route of Administration Intravenous
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV
Editor Type none
Dose 1 Undisclosed dose 1
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2023-10-27
Completion Date 2030-06-30
Last Update 2024-07-23

Participation Criteria


Eligible Age >=18 Years
Standard Ages Adult, Older adult
Eligible Sex MALE

Locations


No.of Trial Sites 1
Locations China

Regulatory Information


Has US IND False
Recent Updates First patient dosed January 2024

Resources/Links