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Clinical Trial Report

Gene Therapy Trial Report

Summary

Halting Ornithine Transcarbamylase Deficiency With Recombinant AAV in ChildrEn


NCTID NCT05092685 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Ornithine Transcarbamylase (OTC) Deficiency
Disease Ontology Term DOID:9271
Compound Name BGT-OTCD
Compound Alias AAVLK03hOTC
Compound Description AAV-based gene therapy vector (serotype LK03) encoding a human codon-optimized OTC gene under the control of the hAAT promotor and hOTC enhancer
Sponsor University College, London
Funder Type Other
Recruitment Status
Enrollment Count 12 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant OTC
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 Liver
Delivery System Viral transduction
Vector Type AAV-LK03
Editor Type none
Dose 1 6E11 vg/kg
Dose 2 2E12 vg/kg
Dose 3 6E12 vg/kg
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2021-09-28
Completion Date 2027-06-30
Last Update 2023-11-07

Participation Criteria


Eligible Age 0 Days - 16 Years
Standard Ages Child
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 1
Locations United Kingdom

Regulatory Information


Has US IND False
FDA Designations Orphan Drug Designation
Recent Updates First patient treated early 2024

Resources/Links